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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 UniversityDate Published: 5/10/2021Format: PDFAnnotation: 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 ToolAccess Notes: Free/Publicly Available
Available Formats: PDF
Contact Information: Harvard University and the University of Witwatersand haalsi@hsph.harvard.eduIncludes Research Tools: Yes.ID: 24246. From: Disaster Lit®a database of the U.S. National Library of Medicine. -
RADx Common Data Elements
Source: National Institutes of Health (NIH)Date Published: 3/25/2021Format: TextAnnotation: 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 ToolAccess Notes: Free/Publicly Available
Available Formats: Text
Contact Information: Dr. Patti Brennan email: patti.brennan@nih.govIncludes Research Tools: Yes.ID: 24244. From: Disaster Lit®a database of the U.S. National Library of Medicine.REDCap: Yes. -
Novel Coronavirus (COVID) Illness - Patient Report (NCI-PR)
Source: New York University (NYU)Date Published: 3/5/2021Format: TextAnnotation: 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 ToolAccess Notes: Free/Publicly Available
Available Formats: Text
Contact Information: Moriah.Thomason@nyulangone.orgIncludes Research Tools: Yes.ID: 24224. From: Disaster Lit®a database of the U.S. National Library of Medicine. -
RADx-UP Common Data Elements
Source: Duke UniversityDate Published: 1/11/2021Format: TextAnnotation: 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 ToolAccess 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.eduIncludes Research Tools: Yes.ID: 24221. From: Disaster Lit®a database of the U.S. National Library of Medicine.REDCap: Yes. -
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. -
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: 12/15/2020Format: TextAnnotation: 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 ToolAccess 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.govIncludes Research Tools: Yes.ID: 24206. From: Disaster Lit®a database of the U.S. National Library of Medicine. -
KFF COVID-19 Vaccine Monitor
Source: Kaiser Family Foundation (KFF)Date Published: 12/15/2020Format: PDFAnnotation: The KFF COVID-19 Vaccine Monitor is an ongoing research project tracking the public's attitudes and experiences with COVID-19 vaccinations. Using a combination of surveys and focus groups, this project tracks the dynamic nature of public opinion as vaccine development unfolds, including vaccine confidence and hesitancy, trusted messengers and messages, as well as the public's experiences with vaccination as distribution begins.
Population: Adults only
Mode of Administration: Telephone
Language(s): English
Data Dashboard: https://www.kff.org/coronavirus-covid-19/dashboard/kff-covid-19-vaccine-monitor-dashboard/
Vaccine Monitor Report Archive https://www.kff.org/coronavirus-covid-19/kff-covid-19-vaccine-monitor-archives/
Website for initial release of Vaccine Monitor: https://www.kff.org/coronavirus-covid-19/report/kff-covid-19-vaccine-monitor-december-2020/...[See more] [See less]Type: Guideline/Assessment ToolAccess Notes: Free/Publicly Available
Available Formats: PDF
Contact Information: Kaiser Family Foundation (KFF) https://www.kff.org/contact-us/Includes Research Tools: Yes.ID: 24234. From: Disaster Lit®a database of the U.S. National Library of Medicine. -
Vaccine Adverse Event Reporting System (VAERS)
Source: Centers for Disease Control and Prevention (CDC)Date Published: 12/2020Format: PDFAnnotation: Established in 1990, the Vaccine Adverse Event Reporting System (VAERS) is a national early warning system to detect possible safety problems in U.S.-licensed vaccines. VAERS is co-managed by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA). VAERS accepts and analyzes reports of adverse events (possible side effects) after a person has received a vaccination. Anyone can report an adverse event to VAERS. Healthcare professionals are required to report certain adverse events and vaccine manufacturers are required to report all adverse events that come to their attention.
VAERS is a passive reporting system, meaning it relies on individuals to send in reports of their experiences to CDC and FDA. VAERS is not designed to determine if a vaccine caused a health problem, but is especially useful for detecting unusual or unexpected patterns of adverse event reporting that might indicate a possible safety problem with a vaccine. This way, VAERS can provide CDC and FDA with valuable information that additional work and evaluation is necessary to further assess a possible safety concern. https://vaers.hhs.gov/reportevent.html
Population: All/Anyone
Length: 28 questions
Mode of Administration: Online (e.g., computer-assisted interview)
Pen and Paper
Administered by: Self Administered
Parent/Teacher
Specialist/Doctor/Expert
Language(s): English...[See more] [See less]Type: Guideline/Assessment ToolAccess Notes: Free/Publicly Available
Information can be reported via an online form or in a PDF that can be uploaded. To find a link to the PDF, and information on how to report the adverse events, go here: https://vaers.hhs.gov/reportevent.html.
Available Formats: PDF
Contact Information: Email: info@vaers.org; Phone: (800) 822-7967; FAX: (877) 721-0366Includes Research Tools: Yes.ID: 24207. From: Disaster Lit®a database of the U.S. National Library of Medicine. -
Health and Retirement Study: Core Interview COVID-19 Module
Source: University of MichiganDate Published: 9/11/2020Format: PDFAnnotation: As a longitudinal study with rich measurement across a large number of social, health, and economic domains, the Health and Retirement Study (HRS) was designed to capture the impact of unexpected societal events, even without additional measurement specific to the event. To complement these longitudinal measures, HRS has developed several areas of content specifically in response to the coronavirus pandemic designed to dovetail with existing assessment. Information on lifestyle and psychosocial functioning is collected through a self-administered questionnaire (SAQ). Additional questions in the psychosocial SAQ were added to the 2020 wave of data collection. These questions obtain information on lifestyle, personal relationships, work, and feelings in response to the pandemic. These questions cover five subtopics: 1) pandemic-specific concerns related to health, finances, friends and family, and the future; 2) changes in social contact with family and friends, including social support given and received and changes in relationship quality; 3) impact on activities including pandemic-specific behaviors such as wearing a mask, washing hands, social distancing, and using hand sanitizer; 4) additional questions about work status that indicate if the respondent was an essential worker and whether or not they could work at home during the pandemic; and 5) emotional well-being, resilience, and coping during the pandemic.
Population: Adults only
Length: 77 questions
Mode of Administration: Online (e.g., computer-assisted interview)
Administered by: Professional Interviewer
Self Administered
Language(s): English
Health and Retirement Study: Core Interview COVID-19 Module: Full Survey https://www.phenxtoolkit.org/toolkit_content/PDF/UMich_HRS_Module.pdf
Direct Experience of COVID-19: General Symptoms; Diagnosis https://www.phenxtoolkit.org/toolkit_content/PDF/UMich_HRS_Module_Experience.pdf
Health Care Access (general): Health Care https://www.phenxtoolkit.org/toolkit_content/PDF/UMich_HRS_Module_Health_Care.pdf
Economic Impact Payments: Economic Insecurity https://www.phenxtoolkit.org/toolkit_content/PDF/UMich_HRS_Module_Payments.pdf
Work and Business: Employment; Economic Impact https://www.phenxtoolkit.org/toolkit_content/PDF/UMich_HRS_Module_Employment.pdf
Living Arrangements: Housing Security; Home Life https://www.phenxtoolkit.org/toolkit_content/PDF/UMich_HRS_Module_Living_Arrangements.pdf
Caregiving: Community Assistance https://www.phenxtoolkit.org/toolkit_content/PDF/UMich_HRS_Module_Caregiving.pdf...[See more] [See less]Type: Guideline/Assessment ToolAccess Notes: Free/Publicly Available
Web page for questionnaires: https://hrs.isr.umich.edu/data-products/covid-19
Web page for documentation, including a codebook: https://hrs.isr.umich.edu/documentation
2020 HRS COVID-19 Project Data https://hrsdata.isr.umich.edu/data-products/2020-hrs-covid-19-project?_ga=2.149722933.267077146.1615987774-1268362274.1611585873
Available Formats: PDF
Contact Information:
David Weir
Director of Health and Retirement Study
dweir@umich.eduIncludes Research Tools: Yes.ID: 23766. From: Disaster Lit®a database of the U.S. National Library of Medicine. -
Hidden Impact of COVID-19 on Children: A Global Research Series
Source: Save the Children InternationalDate Published: 9/10/2020Format: PDFAnnotation: This global study, with several documents, reveals the hidden impacts of COVID-19 pandemic response measures that are impacting children’s health, nutrition, education, learning, protection, well-being, family finances, and poverty.
Population: Adults and teens (NOTE: it’s ages 11 and up, actually)
Length: approximately 100 questions
Time to Complete: 25 minutes
Mode of Administration: Online (e.g., computer-assisted interview)
Administered by: Parent/Teacher; Self Administered
Language(s): English; Albanian; Amharic; Arabic; Bangla; Burmese; Dari; Filipino/Tagalog; French/ Hindi; Iindonesian; Korean; Khmer; Lao; Mongolian; Mindanao; Nepali; Pashto; Portuguese; Serbian; Sinhala; Spanish; Tamil; Thai; Urdu; Vietnamese
Access The Global Research Series reports, findings, and data: https://resourcecentre.savethechildren.net/library/hidden-impact-covid-19-children-global-research-seriesType: ReportAccess Notes: Free/Publicly Available
Contact: Please contact the research team (attn: Melissa Burgess or Silvia Mila Arlini) at evidence.aro@savethechildren.org with any questionsIncludes Research Tools: Yes.ID: 23693. From: Disaster Lit®a database of the U.S. National Library of Medicine.
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