Will the New CDC Opioid Prescribing Guidelines Help Correct the Course in Pain Care?

This Medical News article discusses the 2022 Clinical Practice Guideline for Prescribing Opioids for Pain, an update to widely criticized recommendations released by the CDC in 2016.

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).

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.

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.

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.

Comparison of Opioids Prescribed for Patients at Risk for Opioid Misuse Before and After Publication of the Centers for Disease Control and Prevention's Opioid Prescribing Guidelines.

Importance: It is not known whether decreases in Schedule II (high abuse potential) vs Schedule IV (lower abuse potential) opioid prescriptions overall and among high-risk patients followed publication of the Centers for Disease Control and Prevention (CDC) opioid prescribing guideline on March 15, 2016. Objectives: To compare the odds of new Schedule II opioid (codeine, hydrocodone, oxycodone) prescriptions vs Schedule IV opioid (tramadol) prescriptions in the 18-month periods before and after the CDC guideline release to determine whether new prescriptions for Schedule II opioids decreased relative to new prescriptions for tramadol and to assess whether patients with benzodiazepine prescriptions or those with depression, anxiety, or substance use disorders had a greater decrease in receipt of Schedule II vs Schedule IV opioids. Design, Setting, and Participants: Cross-sectional study of Optum's deidentified Integrated Claims-Clinical data set for 5 million US adults 18 months before and 18 months after March 15, 2016. Eligible patients were 18 years or older, free of HIV and cancer diagnoses, and had a noncancer painful condition. Patients received new prescriptions for codeine, hydrocodone, oxycodone, or tramadol. Data were analyzed from September 5, 2014, to September 14, 2017. Exposure: The CDC opioid prescribing guideline published on March 15, 2016. Main Outcomes and Measures: The odds of prescriptions for each Schedule II opioid vs tramadol after guideline publication. Results: Data from 279 435 patients were included in the study. The mean (SD) age of patients was 52.9 (16.5) years; 61% were female and 79.4% were White. The prevalence of new prescriptions for each drug before and after guideline publication was as follows: codeine, 7.1% vs 7.0%; hydrocodone, 47.4% vs 45.6%; oxycodone, 22.4% vs 24.0%; and tramadol, 23.0% vs 23.4%. Overall, the odds of being prescribed hydrocodone or oxycodone vs tramadol significantly decreased after guideline publication (odds ratios, 0.95; 95% CI, 0.91-0.98 and 0.86; 95% CI, 0.82-0.90, respectively). Odds of being prescribed a Schedule II opioid vs tramadol after vs before guideline publication were similar in patients with and without benzodiazepine comedication or psychiatric disorders. Conclusions and Relevance: In the 18 months after compared with the 18 months before publication of the CDC prescribing guideline, a 14% decrease in oxycodone prescriptions was observed relative to tramadol. Little change in prescriptions of other Schedule II opioids was observed. Schedule II opioids continue to be prescribed to high-risk patients 18 months after publication of the CDC guideline.