Your browser doesn't support javascript.
Show: 20 | 50 | 100
Results 1 - 5 de 5
Filter
2.
Pharmacoepidemiol Drug Saf ; 30(7): 827-837, 2021 07.
Article in English | MEDLINE | ID: covidwho-1192592

ABSTRACT

The US Food and Drug Administration's Sentinel System was established in 2009 to use routinely collected electronic health data for improving the national capability to assess post-market medical product safety. Over more than a decade, Sentinel has become an integral part of FDA's surveillance capabilities and has been used to conduct analyses that have contributed to regulatory decisions. FDA's role in the COVID-19 pandemic response has necessitated an expansion and enhancement of Sentinel. Here we describe how the Sentinel System has supported FDA's response to the COVID-19 pandemic. We highlight new capabilities developed, key data generated to date, and lessons learned, particularly with respect to working with inpatient electronic health record data. Early in the pandemic, Sentinel developed a multi-pronged approach to support FDA's anticipated data and analytic needs. It incorporated new data sources, created a rapidly refreshed database, developed protocols to assess the natural history of COVID-19, validated a diagnosis-code based algorithm for identifying patients with COVID-19 in administrative claims data, and coordinated with other national and international initiatives. Sentinel is poised to answer important questions about the natural history of COVID-19 and is positioned to use this information to study the use, safety, and potentially the effectiveness of medical products used for COVID-19 prevention and treatment.


Subject(s)
COVID-19/therapy , Health Information Management/organization & administration , Product Surveillance, Postmarketing/methods , Public Health Surveillance/methods , United States Food and Drug Administration/organization & administration , Antiviral Agents/therapeutic use , COVID-19/epidemiology , COVID-19/virology , COVID-19 Vaccines/administration & dosage , COVID-19 Vaccines/adverse effects , Communicable Disease Control/legislation & jurisprudence , Databases, Factual/statistics & numerical data , Electronic Health Records/statistics & numerical data , Health Policy , Humans , Pandemics/prevention & control , Pandemics/statistics & numerical data , United States/epidemiology , United States Food and Drug Administration/legislation & jurisprudence
3.
J Am Acad Dermatol ; 84(5): 1254-1268, 2021 05.
Article in English | MEDLINE | ID: covidwho-1014571

ABSTRACT

OBJECTIVE: To update guidance regarding the management of psoriatic disease during the COVID-19 pandemic. STUDY DESIGN: The task force (TF) includes 18 physician voting members with expertise in dermatology, rheumatology, epidemiology, infectious diseases, and critical care. The TF was supplemented by nonvoting members, which included fellows and National Psoriasis Foundation staff. Clinical questions relevant to the psoriatic disease community were informed by inquiries received by the National Psoriasis Foundation. A Delphi process was conducted. RESULTS: The TF updated evidence for the original 22 statements and added 5 new recommendations. The average of the votes was within the category of agreement for all statements, 13 with high consensus and 14 with moderate consensus. LIMITATIONS: The evidence behind many guidance statements is variable in quality and/or quantity. CONCLUSIONS: These statements provide guidance for the treatment of patients with psoriatic disease on topics including how the disease and its treatments affect COVID-19 risk, how medical care can be optimized during the pandemic, what patients should do to lower their risk of getting infected with severe acute respiratory syndrome coronavirus 2 (including novel vaccination), and what they should do if they develop COVID-19. The guidance is a living document that is continuously updated by the TF as data emerge.


Subject(s)
COVID-19 Vaccines , COVID-19/prevention & control , Psoriasis/drug therapy , Biological Products/therapeutic use , COVID-19/complications , COVID-19/drug therapy , COVID-19/epidemiology , Decision Making, Shared , Evidence-Based Medicine , Humans , Immunologic Factors/therapeutic use , Pandemics , Psoriasis/complications , Risk Factors , United States/epidemiology
4.
PLoS Med ; 17(9): e1003379, 2020 09.
Article in English | MEDLINE | ID: covidwho-796633

ABSTRACT

BACKGROUND: There is growing concern that racial and ethnic minority communities around the world are experiencing a disproportionate burden of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and coronavirus disease 2019 (COVID-19). We investigated racial and ethnic disparities in patterns of COVID-19 testing (i.e., who received testing and who tested positive) and subsequent mortality in the largest integrated healthcare system in the United States. METHODS AND FINDINGS: This retrospective cohort study included 5,834,543 individuals receiving care in the US Department of Veterans Affairs; most (91%) were men, 74% were non-Hispanic White (White), 19% were non-Hispanic Black (Black), and 7% were Hispanic. We evaluated associations between race/ethnicity and receipt of COVID-19 testing, a positive test result, and 30-day mortality, with multivariable adjustment for a wide range of demographic and clinical characteristics including comorbid conditions, health behaviors, medication history, site of care, and urban versus rural residence. Between February 8 and July 22, 2020, 254,595 individuals were tested for COVID-19, of whom 16,317 tested positive and 1,057 died. Black individuals were more likely to be tested (rate per 1,000 individuals: 60.0, 95% CI 59.6-60.5) than Hispanic (52.7, 95% CI 52.1-53.4) and White individuals (38.6, 95% CI 38.4-38.7). While individuals from minority backgrounds were more likely to test positive (Black versus White: odds ratio [OR] 1.93, 95% CI 1.85-2.01, p < 0.001; Hispanic versus White: OR 1.84, 95% CI 1.74-1.94, p < 0.001), 30-day mortality did not differ by race/ethnicity (Black versus White: OR 0.97, 95% CI 0.80-1.17, p = 0.74; Hispanic versus White: OR 0.99, 95% CI 0.73-1.34, p = 0.94). The disparity between Black and White individuals in testing positive for COVID-19 was stronger in the Midwest (OR 2.66, 95% CI 2.41-2.95, p < 0.001) than the West (OR 1.24, 95% CI 1.11-1.39, p < 0.001). The disparity in testing positive for COVID-19 between Hispanic and White individuals was consistent across region, calendar time, and outbreak pattern. Study limitations include underrepresentation of women and a lack of detailed information on social determinants of health. CONCLUSIONS: In this nationwide study, we found that Black and Hispanic individuals are experiencing an excess burden of SARS-CoV-2 infection not entirely explained by underlying medical conditions or where they live or receive care. There is an urgent need to proactively tailor strategies to contain and prevent further outbreaks in racial and ethnic minority communities.


Subject(s)
Clinical Laboratory Techniques/statistics & numerical data , Coronavirus Infections/diagnosis , Coronavirus Infections/mortality , Pneumonia, Viral/diagnosis , Pneumonia, Viral/mortality , Veterans/statistics & numerical data , Adult , African Americans/statistics & numerical data , Aged , Aged, 80 and over , Betacoronavirus , COVID-19 , COVID-19 Testing , Cohort Studies , Coronavirus Infections/ethnology , Female , Humans , Male , Middle Aged , Pandemics , Pneumonia, Viral/ethnology , Retrospective Studies , SARS-CoV-2 , United States/epidemiology , Young Adult
5.
J Am Acad Dermatol ; 83(6): 1704-1716, 2020 Dec.
Article in English | MEDLINE | ID: covidwho-744059

ABSTRACT

OBJECTIVE: To provide guidance about management of psoriatic disease during the coronavirus disease 2019 (COVID-19) pandemic. STUDY DESIGN: A task force (TF) of 18 physician voting members with expertise in dermatology, rheumatology, epidemiology, infectious diseases, and critical care was convened. The TF was supplemented by nonvoting members, which included fellows and National Psoriasis Foundation (NPF) staff. Clinical questions relevant to the psoriatic disease community were informed by questions received by the NPF. A Delphi process was conducted. RESULTS: The TF approved 22 guidance statements. The average of the votes was within the category of agreement for all statements. All guidance statements proposed were recommended, 9 with high consensus and 13 with moderate consensus. LIMITATIONS: The evidence behind many guidance statements is limited in quality. CONCLUSION: These statements provide guidance for the management of patients with psoriatic disease on topics ranging from how the disease and its treatments impact COVID-19 risk and outcome, how medical care can be optimized during the pandemic, what patients should do to lower their risk of getting infected with severe acute respiratory syndrome coronavirus 2 and what they should do if they develop COVID-19. The guidance is intended to be a living document that will be updated by the TF as data emerge.


Subject(s)
Coronavirus Infections/epidemiology , Immunosuppressive Agents/adverse effects , Organizations, Nonprofit/standards , Pneumonia, Viral/epidemiology , Psoriasis/drug therapy , Advisory Committees/standards , Betacoronavirus/immunology , Betacoronavirus/pathogenicity , COVID-19 , Consensus , Coronavirus Infections/immunology , Coronavirus Infections/prevention & control , Coronavirus Infections/virology , Critical Care/standards , Delphi Technique , Dermatology/standards , Epidemiology/standards , Humans , Infectious Disease Medicine/standards , Organizations, Nonprofit/organization & administration , Pandemics/prevention & control , Pneumonia, Viral/immunology , Pneumonia, Viral/prevention & control , Pneumonia, Viral/virology , Psoriasis/complications , Psoriasis/immunology , Rheumatology/standards , SARS-CoV-2 , United States/epidemiology
SELECTION OF CITATIONS
SEARCH DETAIL