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  1. HAALSI COVID Survey: Bi-Directional Associations between Cognitive Function and COVID-19 in Health and Aging in Africa: A Longitudinal Study of an INDEPTH Community in South Africa (HAALSI)
    Source: Harvard University
    Date Published: 5/10/2021
    Format: PDF
    Annotation: This survey instrument will be fielded among the existing cohort from the Health and Aging in Africa: A Longitudinal Study of an INDEPTH Community in South Africa (HAALSI), using a Computer-Assisted Telephone Interview (CATI). the survey is intended to collect information on the health, economic, and social impact of the COVID-19 pandemic on older adults in Agincourt, South Africa. The survey is funded by a supplement grant at the National Institute of Aging (NIA), which aims to assess the bi-directional associations between cognitive function and COVID-19 in HAALSI.

    Questions Adapted From: Adapted from similar surveys conducted by other Health and Retirement Survey (HRS) sister studies, including HRS, SHARE, LASI, and ELSA. Questions are also adapted from the main HAALSI survey and the South African Population Research Infrastructure Network (SAPRIN) survey.
    Population: Adults Only
    Length: 74 questions
    Time to Complete: Approximately 20 minutes
    Mode of Administration: Telephone
    Administered by: Professional Interviewer
    Language(s): English, Shangaan
    ...[See more] [See less]
    Type: Guideline/Assessment Tool
    Access Notes: Free/Publicly Available

    Available Formats: PDF

    Contact Information: Harvard University and the University of Witwatersand haalsi@hsph.harvard.edu
    Includes Research Tools: Yes.
    ID: 24246. From: Disaster Lit®a database of the U.S. National Library of Medicine.

  2. RADx Common Data Elements
    Source: National Institutes of Health (NIH)
    Date Published: 3/25/2021
    Format: Text
    Annotation: The RADx program represents an unprecedented investment by the NIH to mitigate the COVID-19 pandemic by accelerating access to testing. There is much to be learned, both in the present as well as over time. To glean the maximum value from the data generated through RADx, all studies involving human participants are required to collect information on 12 key data elements, referred to as common data elements (CDEs).
    Guidance: https://disasterinfo.nlm.nih.gov/content/files/RADx_Exec_Guidance_equired_CDE.docx

    Letter: https://disasterinfo.nlm.nih.gov/content/files/RADX_2021-03-25_Letter.docx
    PDF version: https://disasterinfo.nlm.nih.gov/content/files/RADxExecCommRequiredCDEs2_RADx.pdf
    REDCap: https://disasterinfo.nlm.nih.gov/content/files/RADx%20Exec%20Comm%20Required%20CDEs2%20_%20REDCap.pdf
    Data Dictionary https://disasterinfo.nlm.nih.gov/content/files/RADxExecCommRequiredCDEs2_DataDictionary_2021-04-19.csv


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

    Available Formats: Text

    Contact Information: Dr. Patti Brennan email: patti.brennan@nih.gov
    Includes Research Tools: Yes.
    ID: 24244. From: Disaster Lit®a database of the U.S. National Library of Medicine.
    REDCap: Yes.

  3. Novel Coronavirus (COVID) Illness - Patient Report (NCI-PR)
    Source: New York University (NYU)
    Date Published: 3/5/2021
    Format: Text
    Annotation: Novel Coronavirus (COVID) Illness - Patient Report (NCIPR) is a self-report measure of coronavirus testing, timing, symptoms and treatments. This is a self guided, patient-facing measure. It is recommended that this be administered with the NCIPR-Demographics measure, which includes participant age, brief medical history and additional relevant domains. Novel Coronavirus (COVID) Illness - Patient Report (NCI-PR) https://disasterinfo.nlm.nih.gov/content/files/COVID_Illness_Patient_Report_NCI-PR.pdf
    Novel Coronavirus (COVID) Illness – Patient Report (NCIPR) - Demographics https://disasterinfo.nlm.nih.gov/content/files/COVID_Illness_NCIPR-Demographics.pdf


    Population: Adults only
    Length: 34-87 questions
    Administered by: Self Administered/Self Report
    Language(s): English
    ...[See more] [See less]
    Type: Guideline/Assessment Tool
    Access Notes: Free/Publicly Available

    Available Formats: Text

    Contact Information: Moriah.Thomason@nyulangone.org
    Includes Research Tools: Yes.
    ID: 24224. From: Disaster Lit®a database of the U.S. National Library of Medicine.

  4. COVID-19 Real-time Symptom Epidemiology Tracker (CORSET): Protocol
    Source: Mongan Institute [Massachusetts General Hospital]
    Date Published: 2/8/2021
    Format: Text
    Annotation: The proposed study will contact health care professionals working at Mass General Brigham (Partners Healthcare) or participants enrolled in the Harvard Nurses' Health Study, Harvard Nurses' Health Study II, Harvard Nurses' Health Study III (NHSII/NHSIII), Growing Up Today Study (GUTS), Health Professionals Follow-up Study (HPFS), American Cancer Society Cancer Prevention Study 3 cohorts and direct them to use "COVID-19 Symptom Tracker," a novel app for mobile devices designed to specifically capture self-reported information regarding symptoms associated with COVID-19 and use of PPE during the current COVID-19 pandemic.

    Language(s): English

    This is the protocol for the COVID Symptom Tracker App: https://dr2.nlm.nih.gov/search/?q=21648
    Type: Study Design/Protocol
    Access Notes: Free/Publicly Available

    Available Formats: Text

    Contact Information: predict@mgh.harvard.edu
    Includes Research Tools: Yes.
    ID: 24213. From: Disaster Lit®a database of the U.S. National Library of Medicine.

  5. Coronagenes: Protocol
    Source: University of Edinburgh
    Date Published: 2/8/2021
    Format: Text
    Annotation: An international population cohort to investigate genetic susceptibility to the novel coronavirus (COVID-19). This study seeks to recruit new participants from the general population during the COVID-19 pandemic into a large genetic epidemiological cohort. Recruitment (and subsequent saliva sampling and antibody testing) will take place remotely. Coronagenes re-purposes much of the infrastructure and expertise from the VIKING II study. This launched in January 2020 and paused in March 2020 due to the pandemic, with over 4,000 participants registered. In Coronagenes, data will be collected at baseline through an online questionnaire and longitudinally for UK participants through linkage to routine NHS data (and where possible other healthcare system data) in electronic health records (EHR).

    Language(s): English
    ...[See more] [See less]
    Type: Study Design/Protocol
    Access Notes: Free/Publicly Available

    The is the protocol for the Coronagenes Study: https://dr2.nlm.nih.gov/search/?q=24210

    Available Formats: Text

    Contact Information: Jim Wilson, Professor of Human Genomics, University of Edinburgh Email: jim.wilson@ed.ac.uk
    Includes Research Tools: Yes.
    ID: 24215. From: Disaster Lit®a database of the U.S. National Library of Medicine.

  6. Coronagenes
    Source: University of Edinburgh
    Date Published: 2/5/2021
    Format: PDF
    Annotation: An international population cohort to investigate genetic susceptibility to the novel coronavirus (COVID-19). This study seeks to recruit new participants from the general population during the COVID-19 pandemic into a large genetic epidemiological cohort. Recruitment (and subsequent saliva sampling and antibody testing) will take place remotely. Coronagenes re-purposes much of the infrastructure and expertise from the VIKING II study. This launched in January 2020 and paused in March 2020 due to the pandemic, with over 4,000 participants registered. In Coronagenes, data will be collected at baseline through an online questionnaire and longitudinally for UK participants through linkage to routine NHS data (and where possible other healthcare system data) in electronic health records (EHR).

    Population: All/anyone
    Length: 50 questions
    Language(s): English

    Coronagenes Participant Information Sheet: https://disasterinfo.nlm.nih.gov/content/files/2020-07-08_Coronagenes_PIS_v4.0.docx

    Short Daily Questionnaire Specification: https://disasterinfo.nlm.nih.gov/content/files/Short%20Daily%20Questionnaire%20Specification%20v1.0.pdf
    Coronagenes Volunteer Consent: https://disasterinfo.nlm.nih.gov/content/files/Consent%20Full.PNG

    The protocol for this study can be found in this record: https://dr2.nlm.nih.gov/search/?q=24215
    ...[See more] [See less]
    Type: Guideline/Assessment Tool
    Access Notes: Free/Publicly Available

    Available Formats: PDF

    Contact Information: Jim Wilson, Professor of Human Genomics, University of Edinburgh Email: jim.wilson@ed.ac.uk
    Includes Research Tools: Yes.
    ID: 24210. From: Disaster Lit®a database of the U.S. National Library of Medicine.

  7. RADx-UP Common Data Elements
    Source: Duke University
    Date Published: 1/11/2021
    Format: Text
    Annotation: RADx-UP is a part of RADx, the overall National Institutes of Health (NIH) initiative to help speed innovation in the development and implementation of COVID-19 testing. In order to ensure consistency in how RADx-UP projects collect data for the RADx Data Hub and simplify the analysis of that data, the NIH defined a set of Common Data Elements (CDEs). The NIH CDEs provide a standard set of study questions that RADx-UP projects are required to use in their COVID-19 testing studies. The RADx-UP Coordination and Data Collection Center (CDCC) also provided an Informed Consent Form (ICF) data sharing language template to help standardize the consent process.

    The consistent use of the CDEs and ICF data sharing language by RADx-UP projects will allow the RADx-UP consortium to aggregate data from across all the populations and communities that projects study and engage. In addition, the CDCC will be able to deposit that collected data with the RADx Data Hub, leading to rapid and increased learning about this pandemic.

    REDCap Data Dictionary Codebook PDF: https://radx-up.org/wp-content/uploads/2021/01/RADx-UP-_-REDCap20201230_codebook-.pdf

    RADx-UP Data Dictionary Codebook CSV (updated Jan. 11th): https://radx-up.org/wp-content/uploads/2021/01/RADxUPDev_DataDictionary_2020-12-30.csv
    RADx-UP PDF form for paper data collection: https://radx-up.org/wp-content/uploads/2021/01/RADxUP_20201230_forms.pdf
    Spanish REDCap Data Dictionary Codebook PDF: https://radx-up.org/wp-content/uploads/2021/01/RADxUPDev_ES_20201230_codebook_20210127.pdf
    Spanish REDCap Data Codebook CSV: https://radx-up.org/wp-content/uploads/2021/01/RADxUPDev_DataDictionary_2020-12-30_ES-US_20210127.csv
    Spanish RADx-UP PDF form for paper data collection: https://radx-up.org/wp-content/uploads/2021/01/RADxUPDev_ES_20201230_forms_202010127.pdf
    Data Transfer Agreement
    RADx-UP CDCC Data Transfer Agreement: https://radx-up.org/wp-content/uploads/2021/02/RADx-UP-CDCC-Data-Transfer-Agreement-15Jan21.pdf
    Data Harmonization Guidance
    NIH Guidance on RADx-UP Data Harmonization: https://radx-up.org/wp-content/uploads/2021/01/RADx-UP_Data_Harmonization_Guidance_CDEs.pdf
    Informed Consent Data Sharing
    RADx-UP Informed Consent Data Sharing Template Language: https://radx-up.org/wp-content/uploads/2021/02/RADx-UP-ICF-template_v.1.0_12.30.2020.pdf
    RADx-UP Informed Consent Data Sharing Template Language (Spanish): https://radx-up.org/wp-content/uploads/2021/02/RADx-UP-ICF-template_v.1.0_12.30.2020_ES-US.pdf

    Population: Adults
    Length: 265 questions
    Mode of Administration: Online (e.g., computer-assisted interview), Paper/written
    Language(s): English, Spanish
    ...[See more] [See less]
    Type: Guideline/Assessment Tool
    Access Notes: Free/Publicly Available

    RADx-UP Toolkit https://radx-up.org/toolkit/: The Rapid Acceleration of Diagnostics-Underserved Populations (RADx-UP) Coordination and Data Collection Center (CDCC) toolkit provides resources and materials to support the work of our RADx-UP projects and partners.

    Available Formats: Text

    Contact Information: Laura Johnson (DCRI) Email: laura2.johnson@duke.edu
    Includes Research Tools: Yes.
    ID: 24221. From: Disaster Lit®a database of the U.S. National Library of Medicine.
    REDCap: Yes.

  8. C4R COVID-19 Questionnaire: Collaborative Cohort of Cohorts for COVID-19 Research
    Source: Columbia University
    Date Published: 1/2021
    Format: PDF
    Annotation: The purpose of this questionnaire is to ascertain data on COVID-19 testing, self-reported COVID-19 diagnoses and hospitalizations, symptoms, recovery, re-infection, and vaccination. It also assesses the impact of the pandemic on access to healthcare, finances, health-related behaviors, social interactions, and mood. This questionnaire can be administered to individuals with no prior COVID assessments as well as those with prior COVID assessments. If prior assessments are available, text is provided to guide the interviewer to gather new information.

    Questions Adapted From: Please see page 2 of the questionnaire.
    Population: Adults only
    Mode of Administration: Online (e.g., computer-assisted interview)
    Pen and Paper
    Telephone
    Administered by: Professional Interviewer
    Self Administered
    Specialist/Doctor/Expert
    Trained Lay Examiner/Interviewer
    Language(s): English, Spanish, Chinese
    ...[See more] [See less]
    Type: Guideline/Assessment Tool
    Access Notes: Free/Publicly Available
    Find information about Data collection for the Collaborative Cohort of Cohorts for COVID-19 Research (C4R): https://c4r-nih.org/content/data-collection
    Redcap data dictionary and codebook are available upon request.

    As part of the NIH NHLBI CONNECTS program, the C4R observational study is collecting participant data and samples to better understand COVID-19 and the associated symptoms and side effects. Find more information on the CONNECTS component of the C4R study: https://nhlbi-connects.org/secure/study/6.

    Citation(s):
    C4R Investigators (2020). C4R Questionnaire.

    Available Formats: PDF

    Contact Information: c4r@cumc.columbia.edu
    Includes Research Tools: Yes.
    ID: 24223. From: Disaster Lit®a database of the U.S. National Library of Medicine.
    REDCap: Yes.

  9. 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.

  10. Recommendations for Common Data Elements for COVID-19 Studies Including Pregnant Participants
    Source: National Institute of Child Health and Human Development [National Institutes of Health] (NICHD)
    Date Published: 12/15/2020
    Format: Text
    Annotation: We present a battery of recommended biomedical and psychosocial common data elements (CDEs) and measures that, when combined across datasets, can improve our collective understanding of COVID-19 in pregnant and lactating women and their neonates. Experts across eight large pregnancy cohort studies developed these recommendations for use by any planned or upcoming COVID-19 study that includes women of reproductive age or pregnant women. We encourage researchers to include some or all of these measures, which cover key medical and psychosocial domains relevant to pregnancy and childbirth, into their studies to maximize the potential for data harmonization while continuing to advance their own study goals.

    Common biomedical data elements and measures aim to accelerate our understanding of the clinical course of the disease and its effects on pregnant women and their neonates, which will continue to evolve as treatments and vaccines become available. Here we highlight CDEs and measures across seven domains, which include: Baseline Maternal / Pregnancy Characteristics; Maternal COVID-19 Treatment; Maternal Outcomes; Obstetric / Pregnancy Outcomes; Neonatal Characteristics; Neonatal COVID-19 Testing; and Early Neonatal Outcomes. Recommendations assume that information from all patient visits (e.g., prenatal visits, COVID-19 testing, and delivery) can be collected via medical chart or downloaded data from electronic health records.

    Common psychosocial data elements and measures aim to advance our understanding of the psychological, behavioral, and social effects of the virus and the pandemic on pregnant women and their neonates. Here we highlight CDEs and measures across six domains, including: Socioeconomic Status, Housing, and Emergent Financial Strain; Medical Care; Impact on Parenting; Stressful Life Events; Maternal Mental Health; and Health Related Behaviors.

    Questions Adapted From: The majority of the recommended CDEs are already in use in ongoing COVID-19 studies, as indicated below and in footnotes throughout.

    Biomedical: Adapted from Maternal Fetal Medicine Unit (GRAVID) COVID-19 and Delivery Case Report Forms with additional input from the Study of Pregnancy and Neonatal Health (SPAN) and other ongoing or planned studies.

    Psychosocial: The source for each question is provided in the footnotes.

    A full list of sources used is as follows:

    ­ 2020 COVID-19 Household Pulse Survey https://www.census.gov/data/experimental-data-products/household-pulse-survey.html
    ;
    ­ All of Us Research Program: COVID-19 Participant Experience Survey (COPE) https://www.nlm.nih.gov/dr2/COPE_Survey_NIH_All_of_Us_Clean_4.27.20.pdf;
    ­ Brief Resilient Coping Scale (from MACS-WIHS Baseline COVID-19 Abbreviated Questionnaire) https://www.nlm.nih.gov/dr2/MACS-WIHS_questionnaire_BLCOVID-040620.pdf;
    ­ Columbia COVID-19 Questionnaire http://www.columbiamedicine.org/divisions/kiryluk/study_covid19.php;
    ­ Coronavirus Health Impact Survey (CRISIS) https://www.nlm.nih.gov/dr2/CRISIS_Parent_Caregiver_Follow_Up_Current_Form_V0.3.pdf;
    ­ Coronavirus Perinatal Experiences-Impact Survey (COPE-IS) https://www.nlm.nih.gov/dr2/COPE-Impact_Survey_Perinatal_Pandemic_Survey.pdf;
    ­ Environmental Influences on Child Health Outcomes (ECHO) COVID-19 Questionnaire https://www.nlm.nih.gov/dr2/C19-aPV_COVID-19_Questionnaire-Adult_Primary_Version_20200409_v01.30.pdf;
    ­ Everyday Discrimination Scale (Short version) https://scholar.harvard.edu/files/davidrwilliams/files/measuring_discrimination_resource_june_2016.pdf;
    ­ GAD 7 https://med.dartmouth-hitchcock.org/documents/GAD-7-anxiety-screen.pdf;
    ­ Impact of Event Scale-6 https://www.researchgate.net/publication/26250275_Brief_measure_of_posttraumatic_stress_reactions_Impact_of_Event_Scale-6;
    ­ Infant Feeding Practices Study II https://www.cdc.gov/breastfeeding/data/ifps/questionnaires.htm;
    ­ Intimate Partner Violence ACOG Practice Bulletin https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2012/02/intimate-partner-violence ;
    ­ JHU Community Response https://www.nlm.nih.gov/dr2/JHU_COVID-19_Community_Response_Survey_v1.3.pdf ;
    ­ MACS-WIHS Baseline COVID-19 Abbreviated Questionnaire https://www.nlm.nih.gov/dr2/MACS-WIHS_questionnaire_BLCOVID-040620.pdf;
    ­ National Health and Nutrition Examination Survey (NHANES), Demographics Module, 2019-2020 https://wwwn.cdc.gov/nchs/nhanes/continuousnhanes/questionnaires.aspx?BeginYear=2019;
    ­ PhenX: Health Reform Monitoring Survey 2015 https://www.phenxtoolkit.org/protocols/view/11502;
    ­ PhenX: 6 item standard measure from USDA Economic Research Service https://www.phenxtoolkit.org/protocols/view/270301#tabsource;
    ­ PhenX: Edinburgh Postnatal Depression Scale (EPDS) https://www.phenxtoolkit.org/protocols/view/241401;
    ­ PhenX: Panel Study of Income Dynamics (PSID), 2007 https://www.phenxtoolkit.org/protocols/view/11301;
    ­ PhenX: Pregnancy Risk Assessment Monitoring System (PRAMS) https://www.phenxtoolkit.org/protocols/view/720901;
    ­ Pittsburgh Hill / Homewood Research on Neighborhood Change and Health (PHRESH) https://drive.google.com/file/d/1q9DOJGNT7oe_KGMUXFCi73vIu57W3D3O/view;
    ­ Postpartum Bonding Questionnaire https://sundspsykologerna.se/files/Brockington-et-al-2006-PBQ-validation-pdf.pdf;
    ­ RAND American Life Panel Impact of COVID-19 Survey https://www.phenxtoolkit.org/toolkit_content/PDF/RAND_ALP_COVID19.pdf;
    ­ Stanford COVID-19 Community Outcomes (COCO) Survey https://drive.google.com/file/d/1zHnqLG-I8Htl6SdhyFxuJzP_qYRFPgKi/view;
    ­ Study of Pregnancy and Neonatal Health (SPAN) https://www.nichd.nih.gov/about/org/diphr/officebranch/eb/SPAN: Attained measures via personal communication

    Population: Adult Workers
    Adults and Teens
    First Responders, Emergency Medical Services (EMS) Personnel, Police/Fire Departments
    Military
    Pregnant or Lactating Women

    Length: There are a total of 121 questions within the tool, 49 of which fall under Biomedical data elements, and 72 of which fall under Psychosocial data elements

    Time to Complete: Approximately 20 minutes to complete all questions included in the Psychosocial measure.

    Mode of Administration: Face-to-face
    Online (e.g., computer-assisted interview)
    Pen and Paper
    Telephone

    Administered by: Lay Interviewer
    Professional Interviewer
    Self Administered
    Specialist/Doctor/Expert
    Trained Lay Examiner/Interviewer

    Special Considerations: The recommendations herein are not meant to be distributed as one comprehensive questionnaire, but rather represent the recommended measures for collecting information regarding the most important data elements to assess in relation the effects of COVID-19 on pregnant women and their neonates. We encourage researchers to include some or all of these measures into their studies to maximize the potential for data harmonization while continuing to advance their own study goals.

    Language(s): English
    ...[See more] [See less]
    Type: Guideline/Assessment Tool
    Access Notes: Free/Publicly Available

    "Promoting Data Harmonization to Accelerate COVID-19 Pregnancy Research", February 2021. https://disasterinfo.nlm.nih.gov/content/files/NIHPromotin%20DataHarmonizationAccelerateCOVID19PregnancyResearchBiomedicalPsychosocialBiospecimens_vF.pdf

    Available Formats: TEXT

    Contact Information: Caroline Signore, NICHD, signorec@mail.nih.gov; Nahida Chakhtoura, NICHD, Nahida.chakhtoura@nih.gov; Jessica Gleason, NICHD, Jessica.gleason@nih.gov; Stephen Gilman, NICHD, Stephen.gilman@nih.gov
    Includes Research Tools: Yes.
    ID: 24206. From: Disaster Lit®a database of the U.S. National Library of Medicine.

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