Considerations for Improving Reporting and Analysis of Date-Based COVID-19 Surveillance Data by Public Health Agencies.

More than a year after the first domestic COVID-19 cases, the United States does not have national standards for COVID-19 surveillance data analysis and public reporting. This has led to dramatic variations in surveillance practices among public health agencies, which analyze and present newly confirmed cases by a wide variety of dates. The choice of which date to use should be guided by a balance between interpretability and epidemiological relevance. Report date is easily interpretable, generally representative of outbreak trends, and available in surveillance data sets. These features make it a preferred date for public reporting and visualization of surveillance data, although it is not appropriate for epidemiological analyses of outbreak dynamics. Symptom onset date is better suited for such analyses because of its clinical and epidemiological relevance. However, using symptom onset for public reporting of new confirmed cases can cause confusion because reporting lags result in an artificial decline in recent cases. We hope this discussion is a starting point toward a more standardized approach to date-based surveillance. Such standardization could improve public comprehension, policymaking, and outbreak response. (Am J Public Health. 2021;111(12):2127-2132. https://doi.org/10.2105/AJPH.2021.306520).

Protecting Privacy and Transforming COVID-19 Case Surveillance Datasets for Public Use.

OBJECTIVES: Federal open-data initiatives that promote increased sharing of federally collected data are important for transparency, data quality, trust, and relationships with the public and state, tribal, local, and territorial partners. These initiatives advance understanding of health conditions and diseases by providing data to researchers, scientists, and policymakers for analysis, collaboration, and use outside the Centers for Disease Control and Prevention (CDC), particularly for emerging conditions such as COVID-19, for which data needs are constantly evolving. Since the beginning of the pandemic, CDC has collected person-level, de-identified data from jurisdictions and currently has more than 8 million records. We describe how CDC designed and produces 2 de-identified public datasets from these collected data. METHODS: We included data elements based on usefulness, public request, and privacy implications; we suppressed some field values to reduce the risk of re-identification and exposure of confidential information. We created datasets and verified them for privacy and confidentiality by using data management platform analytic tools and R scripts. RESULTS: Unrestricted data are available to the public through Data.CDC.gov, and restricted data, with additional fields, are available with a data-use agreement through a private repository on GitHub.com. PRACTICE IMPLICATIONS: Enriched understanding of the available public data, the methods used to create these data, and the algorithms used to protect the privacy of de-identified people allow for improved data use. Automating data-generation procedures improves the volume and timeliness of sharing data.

Validation of High-Sensitivity Severe Acute Respiratory Syndrome Coronavirus 2 Testing for Stool-Toward the New Normal for Fecal Microbiota Transplantation.

INTRODUCTION: Mounting evidence demonstrates potential for fecal-oral transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The US Food and Drug Administration now requires SARS-CoV-2 testing of potential feces donors before the use of stool manufactured for fecal microbiota transplantation. We sought to develop and validate a high-sensitivity SARS-CoV-2 reverse transcriptase polymerase chain reaction (RT-PCR) procedure for testing stool specimens. METHODS: A modified extraction method was used with an RT-PCR assay adapted from the Centers for Disease Control and Prevention PCR protocol for respiratory specimens. Contrived specimens were created using pre-COVID-19 banked stool specimens and spiking in known concentrations of SARS-CoV-2-specific nucleic acid. The highest transcript concentration at which 2/2 or 1/2 SARS-CoV-2 targets were detected in 9/10 replicates was defined as the dual-target limit and single-target limit of detection, respectively. The clinical performance of the assay was evaluated with stool samples collected from 17 nasopharyngeal swab RT-PCR-positive patients and 14 nasopharyngeal RT-PCR-negative patients. RESULTS: The dual-target and single-target limit of detection were 56 copies/µL and 3 copies/µL, respectively. SARS-CoV-2 was detected at concentrations as low as 0.6 copies/µL. Clinical stool samples from known COVID-19-positive patients demonstrated the detection of SARS-CoV-2 in stool up to 29 days from symptom onset with a high agreement with nasopharyngeal swab tests (kappa statistic of 0.95, P value < 0.001). DISCUSSION: The described RT-PCR test is a sensitive and flexible approach for the detection of SARS-CoV-2 in stool specimens. We propose an integrated screening approach that incorporates this stool test to support continuation of fecal microbiota transplantation programs.

Stethoscope hygiene: A call to action. Recommendations to update the CDC guidelines.

Healthcare-acquired infections are a tremendous challenge to the US medical system. Stethoscopes touch many patients, but current guidance from the Centers for Disease Control and Prevention does not support disinfection between each patient. Stethoscopes are rarely disinfected between patients by healthcare providers. When cultured, even after disinfection, stethoscopes have high rates of pathogen contamination, identical to that of unwashed hands. The consequence of these practices may bode poorly in the coronavirus 2019 disease (COVID-19) pandemic. Alternatively, the CDC recommends the use of disposable stethoscopes. However, these instruments have poor acoustic properties, and misdiagnoses have been documented. They may also serve as pathogen vectors among staff sharing them. Disposable aseptic stethoscope diaphragm barriers can provide increased safety without sacrificing stethoscope function. We recommend that the CDC consider the research regarding stethoscope hygiene and effective solutions to contemporize this guidance and elevate stethoscope hygiene to that of the hands, by requiring stethoscope disinfection or change of disposable barrier between every patient encounter.

Presenting or Spinning Facts? Deconstructing the U.S. Centers for Disease Control Statement on the Importance of Reopening Schools Under COVID-19.

Credible, reliable and consistent information to the public, as well as health professionals and decision makers, is crucial to help navigate uncertainty and risk in times of crisis and concern. Traditionally, information and health communications issued by respected and established government agencies have been regarded as factual, unbiased and credible. The U.S. Centers for Disease Control and Prevention (CDC) is such an agency that addresses all aspects of health and public health on behalf of the U.S Government for the benefit of its citizens. In July 2020, the CDC issued guidelines on reopening schools which resulted in open criticism by the U.S. President and others, prompting a review and publication of revised guidelines together with a special "Statement on the Importance of Reopening Schools under COVID-19." We hypothesize that this statement introduced bias with the intention to shift the public perception and media narrative in favor of reopening of schools. Using a mixed methods approach, including an online text analysis tool, we demonstrate that document title and structure, word frequencies, word choice, and website presentation did not provide a balanced account of the complexity and uncertainty surrounding school reopening during the COVID-19 pandemic. Despite available scientific guidance and practical evidence-based advice on how to manage infection risks when reopening schools, the CDC Statement was intentionally overriding possible parent and public health concerns. The CDC Statement provides an example of how political influence is exercised over the presentation of science in the context of a major pandemic. It was withdrawn by the CDC in November 2020.

An Overview Of Vaccine Development, Approval, And Regulation, With Implications For COVID-19.

The Food and Drug Administration (FDA) approves vaccines when their benefits outweigh the risks for their intended use. In this article we review the standard FDA approach to vaccine evaluation, which underpins its current approaches to assessment of vaccines to prevent coronavirus disease 2019 (COVID-19). The FDA has established pathways to accelerate vaccine availability before approval, such as Emergency Use Authorization, and to channel resources to high-priority products and allow more flexibility in the evidence required for approval, including accelerated approval based on surrogate markers of effectiveness. Among the thirty-five new vaccines approved in the US from 2006 through October 2020, about two-thirds of their pivotal trials used the surrogate outcome of immune system response, and only one-third evaluated actual disease incidence. Postapproval safety surveillance of new vaccines, and particularly vaccines receiving expedited approval, is crucial. This has generally been accomplished through such mechanisms as the Centers for Disease Control and Prevention (CDC) and FDA Vaccine Adverse Event Reporting System, the CDC Vaccine Safety Datalink, and the CDC Clinical Immunization Safety Assessment Project. Adverse events detected in this way may lead to changes in a vaccine's recommended use or withdrawal from the market. Regulatory oversight of new vaccines must balance speed with rigor to effectively address the pandemic.

Americans' COVID-19 Stress, Coping, and Adherence to CDC Guidelines.

IMPORTANCE: Documenting Americans' stress responses to an unprecedented pandemic and their degree of adherence to CDC guidelines is essential for mental health interventions and policy-making. OBJECTIVE: To provide the first snapshot of immediate impact of COVID-19 on Americans' stress, coping, and guideline adherence. DESIGN: Data were collected from an online workers' platform for survey research (Amazon's Mechanical Turk) from April 7 to 9, 2020. The current data represents the baseline of a longitudinal study. Best practices for ensuring high-quality data were employed. PARTICIPANTS: Individuals who are 18 years of age or older, living in the USA, and English-speaking were eligible for the study. Of 1086 unique responses, 1015 completed responses are included. SETTING: Population-based. MAIN OUTCOMES: Exposure to and stressfulness of COVID-19 stressors, coping strategies, and adherence to CDC guidelines. RESULTS: The sample was 53.9% women (n = 547), with an average age of 38.9 years (SD = 13.50, range = 18-88), most of whom were White (n = 836, 82.4%), non-Hispanic (n = 929, 91.5%), and straight/heterosexual (n = 895, 88.2%); 40% were currently married (n = 407), and 21.6% (n = 219) were caregivers. About half (50.5%) endorsed having at least "mostly" enough money to meet their needs. Respondents' locations across the USA ranged from 18.5% in the Northeast to 37.8% in the South. The most commonly experienced stressors were reading/hearing about the severity and contagiousness of COVID-19, uncertainty about length of quarantine and social distancing requirements, and changes to social and daily personal care routines. Financial concerns were rated most stressful. Younger age, female gender, and caregiver status increased risk for stressor exposure and greater degree of stressfulness. The most frequently reported strategies to manage stress were distraction, active coping, and seeking emotional social support. CDC guideline adherence was generally high, but several key social distancing and hygiene behaviors showed suboptimal adherence, particularly for men and younger adults. CONCLUSIONS AND RELEVANCE: Americans have high COVID-19 stress exposure and some demographic subgroups appear particularly vulnerable to stress effects. Subgroups less likely to adhere to CDC guidelines may benefit from targeted information campaigns. these findings may guide mental health interventions and inform policy-making regarding implications of specific public health measures.

Conservation of personal protective equipment for head and neck cancer surgery during COVID-19 pandemic.

BACKGROUND: COVID-19 pandemic has led to a global shortage of personal protective equipment (PPE). This study aims to stratify face shield needs when performing head and neck cancer surgery. METHODS: Fifteen patients underwent surgery between March 1, 2020 and April 9, 2020. Operative diagnosis and procedure; droplet count and distribution on face shields were documented. RESULTS: Forty-five surgical procedures were performed for neck nodal metastatic carcinoma of unknown origin (n = 3); carcinoma of tonsil (n = 2), tongue (n = 2), nasopharynx (n = 3), maxilla (n = 1), and laryngopharynx (n = 4). Droplet contamination was 57.8%, 59.5%, 8.0%, and 0% for operating, first and second assistant surgeons, and scrub nurse respectively. Droplet count was highest and most widespread during osteotomies. No droplet splash was noted for transoral robotic surgery. CONCLUSION: Face shield is not a mandatory adjunctive PPE for all head and neck surgical procedures and health care providers. Judicious use helps to conserve resources during such difficult times.