Chapter 5: Major Multi-Stakeholder Initiatives — Defining the Future of COVID-19 Observational Research

References

  1. COVID-19 Map. Johns Hopkins Coronavirus Resource Center. Accessed January 11, 2022. https://coronavirus.jhu.edu/map.html
  2. Dong E, Du H, Gardner L. An interactive web-based dashboard to track COVID-19 in real time. Lancet Infect Dis. 2020;20(5):533-534. doi:10.1016/S1473-3099(20)30120-1
  3. CSSEGISandData. COVID-19 Data Repository by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University.; 2022. Accessed January 11, 2022. https://github.com/CSSEGISandData/COVID-19/blob/06bd71bbb5611032a2aa36ce30b21ff65887f0ed/csse_covid…
  4. Home | Margolis Center for Health Policy. Accessed January 11, 2022. https://healthpolicy.duke.edu/
  5. McClellan M, Gottlieb S, Allen J, Borio L, Tenaerts P. Building the Critical Path for COVID-19 Therapeutics. Published online May 20, 2020. Accessed January 18, 2022. https://healthpolicy.duke.edu/sites/default/files/2020-06/building_the_critical_path_for_covid-19_t…
  6. U.S. Food and Drug Administration. Coronavirus Disease 2019 (COVID-19). Published January 14, 2022. Accessed January 18, 2022. https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coron…
  7. OHDSI – Observational Health Data Sciences and Informatics. Accessed January 11, 2022. https://www.ohdsi.org/
  8. Data Standardization – OHDSI. Accessed January 11, 2022. https://ohdsi.org/data-standardization/
  9. Software Tools – OHDSI. Accessed January 11, 2022. https://ohdsi.org/software-tools/
  10. Chen R, Ryan P, Natarajan K, et al. Treatment Patterns for Chronic Comorbid Conditions in Patients With Cancer Using a Large-Scale Observational Data Network. JCO Clinical Cancer Informatics. 2020;4. doi:10.1200/CCI.19.00107
  11. European Health Data Evidence Network. ehden.eu. Accessed January 11, 2022. https://www.ehden.eu/
  12. COVID19 Study-a-thon 2020. ehden.eu. Accessed January 11, 2022. https://www.ehden.eu/covid19-study-a-thon/
  13. OHDSI Studies. GitHub. Accessed January 11, 2022. https://github.com/ohdsi-studies
  14. COVID-19 Updates Page – OHDSI. Accessed January 11, 2022. https://ohdsi.org/covid-19-updates/
  15. List of OHDSI Working Groups. Observational Health Data Sciences and Informatics. Accessed January 11, 2022. https://www.ohdsi.org/web/wiki/doku.php?id=projects:overview
  16. Burn E, You SC, Sena AG, et al. Deep phenotyping of 34,128 adult patients hospitalised with COVID-19 in an international network study. Nat Commun. 2020;11(1):5009. doi:10.1038/s41467-020-18849-z
  17. Morales DR, Conover MM, You SC, et al. Renin–angiotensin system blockers and susceptibility to COVID-19: an international, open science, cohort analysis. The Lancet Digital Health. 2021;3(2):e98-e114. doi:10.1016/S2589-7500(20)30289-2
  18. Lane JCE, Weaver J, Kostka K, et al. Risk of hydroxychloroquine alone and in combination with azithromycin in the treatment of rheumatoid arthritis: a multinational, retrospective study. The Lancet Rheumatology. 2020;2(11):e698-e711. doi:10.1016/S2665-9913(20)30276-9
  19. Duarte-Salles T, Vizcaya D, Pistillo A, et al. Thirty-Day Outcomes of Children and Adolescents With COVID-19: An International Experience. Pediatrics. 2021;148(3):e2020042929. doi:10.1542/peds.2020-042929
  20. Tan EH, Sena AG, Prats-Uribe A, et al. COVID-19 in patients with autoimmune diseases: characteristics and outcomes in a multinational network of cohorts across three countries. Rheumatology. 2021;60(SI):SI37-SI50. doi:10.1093/rheumatology/keab250
  21. Recalde M, Roel E, Pistillo A, et al. Characteristics and outcomes of 627 044 COVID-19 patients living with and without obesity in the United States, Spain, and the United Kingdom. Int J Obes. 2021;45(11):2347-2357. doi:10.1038/s41366-021-00893-4
  22. Roel E, Pistillo A, Recalde M, et al. Characteristics and Outcomes of Over 300,000 Patients with COVID-19 and History of Cancer in the United States and Spain. Cancer Epidemiol Biomarkers Prev. 2021;30(10):1884-1894. doi:10.1158/1055-9965.EPI-21-0266
  23. Prats-Uribe A, Sena AG, Lai LYH, et al. Use of repurposed and adjuvant drugs in hospital patients with covid-19: multinational network cohort study. BMJ. Published online May 11, 2021:n1038. doi:10.1136/bmj.n1038
  24. Reps JM, Kim C, Williams RD, et al. Implementation of the COVID-19 Vulnerability Index Across an International Network of Health Care Data Sets: Collaborative External Validation Study. JMIR Med Inform. 2021;9(4):e21547. doi:10.2196/21547
  25. Homepage | Sentinel Initiative. Accessed January 11, 2022. https://www.sentinelinitiative.org/
  26. Center for Drug Evaluation and Research. FDA’s Sentinel Initiative. FDA. Published October 18, 2019. Accessed January 11, 2022. https://www.fda.gov/safety/fdas-sentinel-initiative
  27. How Sentinel Gets Its Data | Sentinel Initiative. Accessed January 11, 2022. https://www.sentinelinitiative.org/about/how-sentinel-gets-its-data
  28. U.S. Food and Drug Administration. Office of Counterterrorism and Emerging Threats. Published December 8, 2021. Accessed January 11, 2022. https://www.fda.gov/about-fda/office-chief-scientist/office-counterterrorism-and-emerging-threats
  29. Methods, Data, & Tools | Sentinel Initiative. Accessed January 11, 2022. https://www.sentinelinitiative.org/methods-data-tools
  30. Allotey J, Stallings E, Bonet M, et al. Clinical manifestations, risk factors, and maternal and perinatal outcomes of coronavirus disease 2019 in pregnancy: living systematic review and meta-analysis. BMJ. Published online September 1, 2020:m3320. doi:10.1136/bmj.m3320
  31. Ellington S, Strid P, Tong VT, et al. Characteristics of Women of Reproductive Age with Laboratory-Confirmed SARS-CoV-2 Infection by Pregnancy Status — United States, January 22–June 7, 2020. MMWR Morb Mortal Wkly Rep. 2020;69(25):769-775. doi:10.15585/mmwr.mm6925a1
  32. Cocoros NM, Fuller CC, Adimadhyam S, et al. A COVID‐19‐ready public health surveillance system: The Food and Drug Administration’s Sentinel System. Pharmacoepidemiol Drug Saf. 2021;30(7):827-837. doi:10.1002/pds.5240
  33. Master Protocol Development: COVID-19 Natural History | Sentinel Initiative. Accessed January 11, 2022. https://www.sentinelinitiative.org/methods-data-tools/methods/master-protocol-development-covid-19-…
  34. Perez-Vilar S, Martinez AI, Shinde M, et al. Outpatient-Identified COVID-19 and Subsequent Hospitalized Thrombotic Events. :4.
  35. Kempner ME, Shinde M, Hartman J, Lyons J, Stojanovic D, Kit B. Natural History of Coagulopathy in Patients with COVID-19 in a Real-World Electronic Health Data Network. :23.
  36. Martinez AI, Perez-Vilar S, Shinde M, et al. Comparing outcomes in trial-eligible vs real-world COVID-19 patients: The case of invasive mechanical ventilation. Pharmacoepidemiology and Drug Safety. Published online 2021:97-97.
  37. Shinde M, Andrade S, Lyons JG, et al. COVID-19 Pregnancy Study Protocol. Published online May 19, 2021. Accessed January 11, 2022. https://www.sentinelinitiative.org/sites/default/files/documents/Pregnancy_Protocol_COVID_19.pdf
  38. Near Real-Time Monitoring of Critical Drugs for the Care of Patients with COVID-19 | Sentinel Initiative. Accessed January 11, 2022. https://www.sentinelinitiative.org/methods-data-tools/methods/near-real-time-monitoring-critical-dr…
  39. U.S. Food and Drug Administration. In Brief: FDA Provides Guidance on Master Protocols for Evaluating Prevention, Treatment Options for COVID-19. FDA. Published May 17, 2021. Accessed January 11, 2022. https://www.fda.gov/news-events/press-announcements/fda-brief-fda-provides-guidance-master-protocol…
  40. OpenSAFELY: Home. Accessed January 11, 2022. https://www.opensafely.org/
  41. Oxford DataLab | Practical health data analytics. Accessed January 11, 2022. https://www.thedatalab.org/
  42. Electronic Health Records (EHR) Research Group. LSHTM. Accessed January 11, 2022. https://www.lshtm.ac.uk/research/centres-projects-groups/electronic-health-records
  43. Release files from the server - OpenSAFELY documentation. Accessed January 11, 2022. https://docs.opensafely.org/releasing-files/
  44. OpenCodelists. Accessed January 11, 2022. https://www.opencodelists.org/
  45. ICNARC – Intensive Care National Audit & Research Centre. Accessed January 11, 2022. https://www.icnarc.org/
  46. ISARIC • ISARIC. Accessed January 11, 2022. https://isaric.tghn.org/
  47. SGSS and CHESS data. NHS Digital. Accessed January 11, 2022. https://digital.nhs.uk/about-nhs-digital/corporate-information-and-documents/directions-and-data-pr…
  48. The OpenSAFELY Collaborative, Curtis HJ, Inglesby P, et al. Trends and Clinical Characteristics of COVID-19 Vaccine Recipients: A Federated Analysis of 57.9 Million Patients’ Primary Care Records in Situ Using OpenSAFELY. Public and Global Health; 2021. doi:10.1101/2021.01.25.21250356
  49. The Health Service (Control of Patient Information) Regulations 2002. Accessed January 11, 2022. https://www.legislation.gov.uk/uksi/2002/1438/regulation/3/made
  50. Williamson EJ, Walker AJ, Bhaskaran K, et al. Factors associated with COVID-19-related death using OpenSAFELY. Nature. 2020;584(7821):430-436. doi:10.1038/s41586-020-2521-4
  51. Bhaskaran K, Bacon S, Evans SJ, et al. Factors associated with deaths due to COVID-19 versus other causes: population-based cohort analysis of UK primary care data and linked national death registrations within the OpenSAFELY platform. The Lancet Regional Health - Europe. 2021;6:100109. doi:10.1016/j.lanepe.2021.100109
  52. Schultze A, Walker AJ, MacKenna B, et al. Risk of COVID-19-related death among patients with chronic obstructive pulmonary disease or asthma prescribed inhaled corticosteroids: an observational cohort study using the OpenSAFELY platform. Lancet Respir Med. 2020;8(11):1106-1120. doi:10.1016/S2213-2600(20)30415-X
  53. COVID-19 Rapid Guideline: Severe Asthma. National Institute for Health and Care Excellence (NICE); 2020. Accessed January 11, 2022. http://www.ncbi.nlm.nih.gov/books/NBK566868/
  54. Rentsch CT, DeVito NJ, MacKenna B, et al. Effect of pre-exposure use of hydroxychloroquine on COVID-19 mortality: a population-based cohort study in patients with rheumatoid arthritis or systemic lupus erythematosus using the OpenSAFELY platform. The Lancet Rheumatology. 2021;3(1):e19-e27. doi:10.1016/S2665-9913(20)30378-7
  55. Wong AY, MacKenna B, Morton CE, et al. Use of non-steroidal anti-inflammatory drugs and risk of death from COVID-19: an OpenSAFELY cohort analysis based on two cohorts. Ann Rheum Dis. 2021;80(7):943-951. doi:10.1136/annrheumdis-2020-219517
  56. Mathur R, Rentsch CT, Morton CE, et al. Ethnic differences in SARS-CoV-2 infection and COVID-19-related hospitalisation, intensive care unit admission, and death in 17 million adults in England: an observational cohort study using the OpenSAFELY platform. The Lancet. 2021;397(10286):1711-1724. doi:10.1016/S0140-6736(21)00634-6
  57. Williamson EJ, McDonald HI, Bhaskaran K, et al. Risks of covid-19 hospital admission and death for people with learning disability: population based cohort study using the OpenSAFELY platform. BMJ. Published online July 14, 2021:n1592. doi:10.1136/bmj.n1592
  58. Forbes H, Morton CE, Bacon S, et al. Association between living with children and outcomes from covid-19: OpenSAFELY cohort study of 12 million adults in England. BMJ. Published online March 18, 2021:n628. doi:10.1136/bmj.n628
  59. Walker AJ, MacKenna B, Inglesby P, et al. Clinical coding of long COVID in English primary care: a federated analysis of 58 million patient records in situ using OpenSAFELY. Br J Gen Pract. 2021;71(712):e806-e814. doi:10.3399/BJGP.2021.0301
  60. OpenSAFELY: secure access to data to deepen our understanding of COVID-19. NHSX. Accessed January 11, 2022. https://www.nhsx.nhs.uk/key-tools-and-info/data-saves-lives/improving-care-through-research-and-inn…
  61. Oxford Population Health. Ben Goldacre - OpenSAFELY.Org.; 2021. Accessed January 11, 2022. https://www.youtube.com/watch?v=6piBlZ0yhvg
  62. Sturkenboom M, Bahri P, Chiucchiuini A, et al. Why we need more collaboration in Europe to enhance post-marketing surveillance of vaccines. Vaccine. 2020;38:B1-B7. doi:10.1016/j.vaccine.2019.07.081
  63. Thurin NH, Pajouheshnia R, Roberto G, et al. From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding. Clin Pharma and Therapeutics. 2022;111(1):321-331. doi:10.1002/cpt.2476
  64. Trifirò G, Coloma PM, Rijnbeek PR, et al. Combining multiple healthcare databases for postmarketing drug and vaccine safety surveillance: why and how? J Intern Med. 2014;275(6):551-561. doi:10.1111/joim.12159
  65. Willame, C, Dodd, C, Gini, R, et al. Background Rates of Adverse Events of Special Interest for Monitoring COVID-19 Vaccines. Zenodo; 2021. doi:10.5281/ZENODO.5255870
  66. A post-authorisation/post-marketing observational study to evaluate the association between exposure to AZD1222 and safety concerns using existing secondary health data sources (COVID-19). ENCEPP. Accessed June 9, 2022. https://www.encepp.eu/encepp/viewResource.htm?id=45704
  67. An Observational Post-Authorization Safety Study to Assess the Safety of Ad26.COV2.S Using European Healthcare Data through VAC4EU (COVID-19). ENCEPP. Accessed June 9, 2022. https://www.encepp.eu/encepp/viewResource.htm?id=45461
  68. Post Conditional Approval Active Surveillance Study Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine. ENCEPP. Accessed June 9, 2022. https://www.encepp.eu/encepp/viewResource.htm?id=44891
  69. Monitoring safety of Spikevax in pregnancy: an observational study using routinely collected health data in five European countries (COVID-19). ENCEPP. Accessed June 9, 2022. https://www.encepp.eu/encepp/viewResource.htm?id=45467
  70. COVID-19 Research Database. COVID-19 Research Database. Accessed January 11, 2022. https://covid19researchdatabase.org/
  71. Talwai A, Wing V, Itzkovich Y, et al. PIN83 The COVID-19 Research Database: Building One of the Largest PRO Bono Real-World DATA Repositories. Value in Health. 2021;24:S121. doi:10.1016/j.jval.2021.04.1271
  72. Lekoubou A, Pelton M, Ba DM, Ssentongo P. Racial Disparities in Ischemic Stroke Among Patients with COVID-19 in the United States. Journal of Stroke and Cerebrovascular Diseases. 2021;30(8):105877. doi:10.1016/j.jstrokecerebrovasdis.2021.105877
  73. Nguyen TD, Gupta S, Ziedan E, et al. Assessment of Filled Buprenorphine Prescriptions for Opioid Use Disorder During the Coronavirus Disease 2019 Pandemic. JAMA Intern Med. 2021;181(4):562. doi:10.1001/jamainternmed.2020.7497
  74. Meiselbach MK, Bai G, Anderson GF. Charges of COVID-19 Diagnostic Testing and Antibody Testing Across Facility Types and States. J GEN INTERN MED. Published online September 15, 2020. doi:10.1007/s11606-020-06198-y
  75. O’Donoghue AL, Biswas N, Dechen T, et al. Trends in Filled Naloxone Prescriptions Before and During the COVID-19 Pandemic in the United States. JAMA Health Forum. 2021;2(5):e210393. doi:10.1001/jamahealthforum.2021.0393
  76. French DD, Chin A, Kathail P. Further Evidence that COVID-19 Disproportionately Impacts African American, Hispanic, and Low-Income Populations. Medium. Published June 16, 2020. Accessed January 11, 2022. https://medium.com/@poojakathail/further-evidence-that-covid-19-disproportionately-impacts-african-…
  77. Galaznik A, Rusli E, Wing V, Jain R, Diamond S, Fajgenbaum D. Assessment of vitamin D deficiency and COVID-19 diagnosis in patients with breast or prostate cancer using electronic medical records. JCO. 2021;39(15_suppl):6589-6589. doi:10.1200/JCO.2021.39.15_suppl.6589
  78. Wing V, Rusli E, Jain R, Galaznik A, Diamond S, Fajgenbaum D. Vitamin D deficiency: Risk of COVID-19 and public health implications. In: APHA; 2021. Accessed January 11, 2022. https://apha.confex.com/apha/2021/meetingapp.cgi/Paper/494152
  79. Meltzer DO, Best TJ, Zhang H, Vokes T, Arora V, Solway J. Association of Vitamin D Status and Other Clinical Characteristics With COVID-19 Test Results. JAMA Netw Open. 2020;3(9):e2019722. doi:10.1001/jamanetworkopen.2020.19722
  80. COVIDRIVE – A public-private partnership for the estimation of brand-specific COVID-19 vaccine effectiveness in Europe. Accessed January 11, 2022. https://covidrive.eu/
  81. European Medicines Agency. Consideration on core requirements for RMPs of COVID-19 vaccines. Published online June 10, 2021. Accessed January 11, 2022. https://www.ema.europa.eu/en/documents/other/consideration-core-requirements-rmps-covid-19-vaccines…
  82. DRIVE - Development of Robust and Innovative Vaccine Effectiveness  Increasing understanding of influenza vaccine effectiveness in Europe. DRIVE. Accessed January 11, 2022. https://www.drive-eu.org/
  83. Study Contributors – COVIDRIVE. Accessed January 11, 2022. https://covidrive.eu/study-contributors/
  84. Bollaerts K, Biccler J, Stuurman A, Aponte Z, Hartig-Merkel W, Rebry G. Master Protocol: Brand-specific COVID-19 vaccine effectiveness against severe COVID-19 disease in Europe. :100.
  85. View Study. Accessed January 11, 2022. https://www.encepp.eu/encepp/viewResource.htm?id=42329
  86. New Public-private Partnership COVIDRIVE To Assess brand-specific COVID-19 Vaccine Effectiveness In Europe. Published online July 19, 2021. Accessed January 11, 2022. https://covidrive.eu/wp-content/uploads/2021/07/COVIDRIVE-official-launch_Press-release_for-website…