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  1. 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.

  2. 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.

  3. 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.

  4. PReventing Emerging Infections through Vaccine EffectiveNess Testing Project: Project PREVENT
    Source: University of Iowa (UI)
    Date Published: 1/13/2021
    Format: PDF
    Annotation: Project PREVENT is a test-negative case-control study of health care personnel (HCP) in 16 US academic medical centers with the following primary objectives: (1) to evaluate post-introduction effectiveness of a complete schedule of SARS-CoV-2 vaccine in preventing laboratory-confirmed symptomatic COVID-19 among HCP (primary objective); (2) to estimate the post-introduction effectiveness of SARS-CoV-2 vaccines in preventing severe disease among those with laboratory-confirmed symptomatic COVID-19; (3) to identify differences in vaccine effectiveness by age group and comorbidity categories; (4) to evaluate vaccine effectiveness in various job categories and clinical practice settings; (5) to estimate the comparative effectiveness of different SARS-CoV-2 vaccines or, for vaccines with 2-dose schedules, 1 vs. 2-doses; (6) to compare health care and COVID-19 testing practices of HCP within specific job groups; (7) to describe quarantine, isolation, repeat testing, and return-to-work practices among vaccinated and unvaccinated HCP tested for COVID-19; (8) to identify factors associated with the decision to be vaccinated for SARS-CoV-2; and (9) to evaluate provider behavior changes, use of infection mitigation strategies, and decision-making in response to COVID-19 vaccination. Data will be collected by enrolling 10,000 HCP in participating sites who develop symptoms of COVID-19, and local project teams will verify (1) vaccination status (COVID-19 and influenza), (2) COVID-19 test results, and (3) healthcare utilization by requesting source document medical records. Modules included in this survey include: (1) participant eligibility/screening form; (2) participant baseline enrollment form/baseline participant survey; (3) participant 6-week follow-up form; (4) clinical trial participation form; (5) weekly facility form; (6) health care utilization abstraction/verification form; (7) vaccination abstraction/verification form; and (8) testing abstraction/verification form. In addition to survey data, medical records will be collected and abstracted to verify exposures and outcomes. Surveys are all administered from a central REDCap system across all sites, and participants are sent survey requests by email and text message. Surveys also can be administered by local site coordinators by telephone, as needed (although all data can be collected without telephone communication). The Data Collection Forms link to Data Dictionary Codebooks.

    Questions Adapted From: Data collection instruments were adapted from "Emerging Infections Program Tracking of SARS-CoV-2 Infections and Assessing Vaccine Effectiveness among Healthcare Personnel," a project of the Centers for Disease Control and Prevention (CDC) Emerging Infections Program.
    Population: Adult Workers
    Length: 562
    Time to Complete: Participant form estimates are as follows: Screening/Eligibility Form - 7 minutes; Baseline Survey - 16 minutes; Follow-up Survey - 12 minutes; Clinical Trial Form - 2 minutes
    Mode of Administration: Online (e.g., computer-assisted interview)
    Telephone
    Administered by: Self Administered
    Trained Lay Examiner/Interviewer
    Special Considerations: All instruments are designed to be self-administered by electronic survey and upload portals, but some participants may provide data through a guided telephone interview by a trained interviewer.
    Language(s): English, Spanish
    ...[See more] [See less]
    Type: Guideline/Assessment Tool
    Access Notes: Free/Publicly Available

    Sections of the Survey tool:
    Baseline Enrollment: https://disasterinfo.nlm.nih.gov/content/files/PREVENT_BaselineEnrollment_1231.pdf;
    Clinical Trial: https://disasterinfo.nlm.nih.gov/content/files/PREVENT_ClinicalTrial_1231.pdf;
    Follow Up: https://disasterinfo.nlm.nih.gov/content/files/PREVENT_FollowUp_1231.pdf;
    Healthcare Abstraction: https://disasterinfo.nlm.nih.gov/content/files/PREVENT_HealthcareAbstraction_1231.pdf;
    Identification: https://disasterinfo.nlm.nih.gov/content/files/PREVENT_Identifification_1231.pdf;
    Screening: https://disasterinfo.nlm.nih.gov/content/files/PREVENT_Screening_1231.pdf;
    Testing Verification: https://disasterinfo.nlm.nih.gov/content/files/PREVENT_TestingVerification_1231.pdf;
    Vaccine Verification: https://disasterinfo.nlm.nih.gov/content/files/PREVENT_VaccineVerification_1231.pdf;
    Weekly Facility: https://disasterinfo.nlm.nih.gov/content/files/PREVENT_WeeklyFacility_1231.pdf

    Available Formats: PDF

    Contact Information: Contact: Nicholas Mohr, MD, MS (nicholas-mohr@uiowa.edu) Project Leadership: Nicholas Mohr, MD (University of Iowa) and Dave Talan, MD (University of California-Los Angeles) Instrument Development Team: Nicholas Mohr, MD (University of Iowa) Dave Talan, MD (University of California-Los Angeles) Anusha Krishnadasan, PhD (University of California-Los Angeles) Karisa Harland, PhD (University of Iowa) Kelli Wallace, MS (University of Iowa) Karin Hoth, PhD (University of Iowa)
    Includes Research Tools: Yes.
    ID: 24208. From: Disaster Lit®a database of the U.S. National Library of Medicine.

  5. 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.

  6. COVID-19 Beliefs, Behaviors & Norms Survey (KAP CoVID Study)
    Source: Johns Hopkins University, Bloomberg School of Public Health
    Date Published: 1/2021
    Format: PDF
    Annotation: This study was implemented in collaboration between John Hopkins Bloomberg School of Public Health's Center for Communication Programs with the Massachusetts Institute of Technology (MIT), the World Health Organization and Facebook's Data for Good. Sixty-nine countries were identified for recruitment of Facebook users at the outset of this study. Countries were selected where Facebook usage was sufficiently widespread and could plausibly result in samples representing a range of national characteristics. Twenty countries were identified as longitudinal (wave) countries and another 49 countries were identified as cross-sectional (snapshot) countries. In the end, two countries were removed due to inadequate response rates.

    Wave 1 Survey: https://ccp.jhu.edu/wp-content/uploads/Global_Survey_Brief_Methods_Section.pdf
    (published July 6, 2020)
    Wave 2 Survey: https://ccp.jhu.edu/wp-content/uploads/Survey-v1-and-v2_jan2021.pdf (published January 2021)

    Population: All/Anyone
    Length: 134 questions
    Language(s): English
    ...[See more] [See less]
    Type: Guideline/Assessment Tool
    Access Notes: Free/Publicly Available
    Find more information on the study: https://covidsurvey.mit.edu/

    Citation(s):
    Collis, A., Garimella, K., Moehring, A., Rahimian, M.A., Babalola, S., Gobat, N., Shattuck, D., Stolow, J., Eckles, D., & Aral, S. (2020). Global survey on COVID-19 beliefs, behaviors, and norms. Technical report, MIT Sloan School of Management https://covidsurvey.mit.edu/covid_survey_files/COVID_BBN_survey_report.pdf

    Available Formats: PDF

    Contact Information: CCPinfo@jhu.edu
    Includes Research Tools: Yes.
    ID: 24216. From: Disaster Lit®a database of the U.S. National Library of Medicine.

  7. 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.

    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.

  8. 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.

  9. Vaccine Adverse Event Reporting System (VAERS)
    Source: Centers for Disease Control and Prevention (CDC)
    Date Published: 12/2020
    Format: PDF
    Annotation: 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 Tool
    Access 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) 721-0366
    Includes Research Tools: Yes.
    ID: 24207. From: Disaster Lit®a database of the U.S. National Library of Medicine.

  10. Health and Retirement Study: Core Interview COVID-19 Module
    Source: University of Michigan
    Date Published: 9/11/2020
    Format: PDF
    Annotation: 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 Tool
    Access 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

    Available Formats: PDF

    Contact Information:
    David Weir
    Director of Health and Retirement Study
    dweir@umich.edu
    Includes Research Tools: Yes.
    ID: 23766. From: Disaster Lit®a database of the U.S. National Library of Medicine.

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