Partners in caring for your patients

Physicians

CHI Memorial has more than 650 physicians on medical staff. With a diverse assortment of medical specialties and sub-specialties, CHI Memorial is equipped to provide the highest quality health care for the vast majority of our community. Many patients from other areas of the country travel to CHI Memorial to seek treatment from our nationally recognized providers.

Your patients are important to us, and we understand your time is precious. We hope you find this physician communication hub on our website beneficial to your practice. 

COVID-19 resources and updates

Current COVID-19 Status:

  • Johns Hopkins Global Coronavirus Tracker: 36,349,500 confirmed; 25,292,503 recovered; 1,058,698 deaths. In the United States, 111,086,971 have been tested; 7,570,173 are confirmed; 2,999,895 have recovered. The United States has a population of 328.2 million people. (10/8/20, 3 p.m.) 
  • 209,447 confirmed cases in Tennessee; 189,990 recovered; 2,705 deaths. Tennessee Department of Health (TDH). 10/8/20  
    • 10,414 confirmed cases in Hamilton County, 9,563 recovered, 101 deaths; 883 cases/856 recovered/4 deaths in Bledsoe County; 3,167cases/ 2,933 recovered/19 deaths in Bradley County; 412 cases/296 recovered/8 deaths in Grundy County; 604 cases/529 recovered/9 deaths Marion County; 1,268 cases/1,112 recovered/29 deaths in McMinn County; 250 confirmed/223 recovered/3 deaths in Meigs County; 929 cases/834 recovered/16 deaths in Rhea County; 262 cases/236 recovered/1 death in Sequatchie County
  • 327,407 confirmed cases in Georgia; 7,294 deaths. 10/8/20 Georgia Department of Public Health (DPH)
    • 1,262 cases, 19 deaths in Catoosa County; 1,655 cases, 39 deaths in Walker; 300 cases, 5 deaths in Dade; 4,770 cases, 63 deaths in Whitfield County; 1,948 cases, 40 deaths in Gordon County.
  • 7,528,313 confirmed cases in the U.S.; 211,132 deaths; 55 jurisdictions (50 states, District of Columbia, Puerto Rico, Guam, Northern Marianas, and US Virgin Islands). CDC 10/8/20

CHI Memorial COVID-19 Response

Visit the resource bank on Mnet for all current COVID-19 information.

 

Key Actions and Updates

*New* PPE Supply Guide Alert

CHI Memorial has tracked its supply of PPE in real time, since the beginning of the COVID-19 pandemic, and measures par levels against documented usage.  This Guide is a confidential internal document and is not to be emailed or shared outside our organization.  Our intent is to make certain that all employees are informed on the exact product that will be stocked by type. Click here to review the Oct. 7 PPE Supply Guide Alert.

 

*New* CommonSpirit Health COVID-19 Bulletin

Important information about the ministry’s response to COVID-19 is published in CommonSpirit Health’s Daily Bulletin. Click here to review the Oct. 6 bulletin. Other editions can be found on the Mnet.

*New* Dr. Labovitz Recommends Flu Vaccine

Rachel Labovitz, MD, internal medicine physician with CHI Memorial Chattanooga Internal Medicine Group, discusses the importance of flu vaccine in 2020.  Watch

 

*New* Health Department Surpasses 100 COVID-19 Deaths in Hamilton County

 

Hamilton County has reached a somber milestone today with the announcement of two additional deaths, bringing the total COVID-19 related deaths of Hamilton County residents to 101.

The announcement comes six months after the first death of a Hamilton County resident was reported on March 25, 2020.

“It is with deep sadness and respect that we honor these 101 lives that have been lost,” said Health Department Administrator Becky Barnes, “These are not just numbers or statistics. Each one of these deaths represents a very real and painful loss to family and friends as well as to our community. Our staff working on the COVID response have developed relationships with many of these patients and their families while monitoring them during their illness.”

In addition to the loss of life, the COVID-19 virus has negatively impacted individuals and families with very real physical pain and suffering as well as mental stress, emotional trauma, and financial hardship.

“While the loss has been heartbreaking, it motivates us to continue our work to protect the health of our community,” Barnes said, “We will continue forward in our efforts and work to decrease, mitigate, and prevent the devastating effects of COVID-19 in our community.”

County residents are encouraged to take a pause and recognize this significant loss that our community has faced. However, we also need to look up and look forward. This is a time to reflect on the positive and not get fatigued. Hamilton County has made progress. With the mask mandate and social distancing—basic day-to-day activities have been able to occur. Students are back in school, most businesses are open, parks and greenways are open.

Hamilton County residents are encouraged to continue taking action to stop the spread and severity of the virus by:

•             Wearing a mask

•             Social distancing

•             Washing hands frequently

•             Avoid large gatherings

•             Staying home and getting tested at the first sign of any COVID-19 symptoms.

Getting this year’s flu vaccine will decrease the threat of an additional respiratory virus that can present with symptoms similar to COVID-19 and also carry risks of hospitalization or death.

Businesses and venues should continue to practice social distancing and other measures as outlined in the TN Pledge.

“With COVID-19 protective measures in place, we can plan for a holiday season that is responsible and safe,” Barnes said, “And not lose the progress we have made on slowing the spread of a virus that has brought our community great loss and required much sacrifice.”

The Health Department continues to offer free COVID-19 testing at the Alstom site 7 days a week, from 8:30AM – 1:00PM. Complete testing and flu vaccine information can be found on the online calendar on their website.

For more information about COVID-19, call the Health Department’s informational hotline at (423) 209-8383.

 

*New* Health Department Offers Free Flu Vaccines for Limited Time

The Hamilton County Health Department will be offering free flu vaccinations for a limited time while supplies last.

•                     A drive-through flu vaccine clinic will be offered for those 18 years or older October 12, 13, and 14 (Monday-Wednesday) from 1:30PM – 5:00PM at the Alstom Plant, 1125 Riverfront Pkwy, Chattanooga, TN 37402.

•                     This is the same location as the COVID-19 testing site, but the flu vaccine clinic will be held at different hours from the COVID-19 testing.

•                     The flu vaccine will be free while supplies last and no appointment is needed.

•                     People will be asked to put on a face mask while in their vehicle before receiving the flu vaccine.

Free flu vaccine for children (ages 6 months through 17 years) is available by appointment only at the following Health Department locations: 

•                     Sequoyah Health Center (209-5490) located at 9527 W Ridge Trail Rd, Soddy-Daisy, TN 37379 or at the

•                     Pediatric Clinic (209-8050) at the downtown Health Department located at 921 E 3rd St, Chattanooga, TN 37403  

The Health Department will open additional flu vaccination clinics as more supplies become available.

For more information about COVID-19 or the flu vaccine, call the Health Department’s hotline at (423) 209-8383 or visit the calendar on their website. The Health Department continues to offer free COVID-19 testing at the Alstom site 7 days a week, from 8:30AM – 1:00PM.

*New* Article from physician e-news: NEJM Editors Blast Trump Administration’s Covid-19 Response 10/7/2020 – Salynn Boyles, Contributing Writer, BreakingMED™

For the first time in its more than 200-year history, the New England Journal of Medicine is weighing in on a U.S. election, calling the Trump administration’s response to the Covid-19 pandemic a national tragedy.

An editorial published Wednesday signed by all 24 NEJM editors characterized the national response to Covid-19 as "consistently inadequate."

"When it comes to the response to the largest public health crisis of our time, our current political leaders have demonstrated that they are dangerously incompetent," the editors wrote.

While the journal editors did not formally endorse the Democratic party nominee, Joe Biden, nor mention President Trump by name, the message was clear.

"With no good options to combat a novel pathogen, countries were forced to make hard choices about how to respond," the editors wrote. "Here in the United States, our leaders have failed that test. They have taken a crisis and turned it into a tragedy."

They added that "the magnitude of that failure is astonishing," noting that the Covid-19 death rate in the U.S. is double that of Canada and 50-times that of Japan, which has a "vulnerable and elderly" population.

"The response of our nation’s leaders has been consistently inadequate," the editorial noted. "The federal government has largely abandoned disease control to the states. Governors have varied in their responses, not so much by party as by competence. But whatever their competence, governors do not have the tools that Washington controls. Instead of using those tools, the federal government has undermined them."

Our nation’s leaders have "undercut trust in science and in government, causing damage that will certainly outlast them," the NEJM editors wrote, adding that the federal government’s leading health organizations have been undermined and diminished during the Covid-19 pandemic.

"The Centers for Disease Control and Prevention, which was the world’s leading disease response organization, has been eviscerated and has suffered dramatic testing and policy failures. The National Institutes of Health have played a key role in vaccine development, but have been excluded from much crucial government decision making. And the Food and Drug Administration has been shamefully politicized, appearing to respond to pressure from the administration rather than scientific evidence…

"Instead of relying on expertise, the administration has turned to uninformed ’opinion leaders’ and charlatans who obscure the truth and facilitate the promulgation of outright lies," the editors added.

In mid-September, the publication Scientific American also broke with tradition to formally call for the election of the former vice president and Democratic party nominee.

In an editorial, the publication’s editors noted that the presidential endorsement was the first in Scientific American’s 175-year history.

"The evidence and the science show that Donald Trump has badly damaged the U.S. and its people — because he rejects evidence and science," the editors wrote, citing not only the administration’s Covid-19 response, but its attack on "environmental protections, medical care and the researchers and public science agencies that help this country prepare for its greatest challenges."

In an interview with the New York Times, published Wednesday, Oct. 7, New England Journal of Medicine editor in chief Eric Rubin, MD, said the editorial was just one of four in the publication’s history signed by all editors of the publication.

Rubin said the editors felt that it was their duty to break with tradition and weigh in on the current political landscape.

"It should be clear that we are not a political organization," he told the New York Times. "But pretty much every week in our editorial meeting there would be some new outrage. How can you not speak out at a time like this?"

The death toll from Covid-19 has exceeded 200,000 and continues to rise in the United States, and the NEJM editors concluded that many of these deaths could have been avoided with adequate federal management of the pandemic.

"Although it is impossible to project the precise number of additional American lives lost because of weak and inappropriate government policies, it is at least in the tens of thousands in a pandemic that has already killed more Americans than any conflict since World War II," they wrote.

Rubin E, et al "Dying in a leadership vacuum" NEJM 2020; DOI: 10.1056/NEJMe2029812.

*New* Article from physician e-news: Distrusting Trump, States Plan to Vet Covid Vaccines Themselves. Bad Idea, Say Experts. 10/7/2020 – JoNel Aleccia and Liz Szabo, Kaiser Health News

As trust in the Food and Drug Administration wavers, several states have vowed to conduct independent reviews of any Covid-19 vaccine the federal agency authorizes.

But top health experts say such vetting may be misguided, even if it reflects a well-founded lack of confidence in the Trump administration — especially now that the FDA has held firm with rules that make a risky preelection vaccine release highly unlikely.

At least six states and the District of Columbia have indicated they intend to review the scientific data for any vaccine approved to fight Covid-19, with some citing concern over political interference by President Donald Trump and his appointees. Officials in New York and California said they are convening expert panels expressly for that purpose.

"Frankly, I’m not going to trust the federal government’s opinion and I wouldn’t recommend [vaccines] to New Yorkers based on the federal government’s opinion," New York Gov. Andrew Cuomo said last month.

"We want to make sure — despite the urge and interest in having a useful vaccine — that we do it with the utmost safety of Californians in mind," Dr. Mark Ghaly, California’s health and human services secretary, said at a recent news conference.

The District of Columbia, Colorado, Michigan, Oregon and West Virginia also have said they’ll review vaccine data independently.

But scientists who study vaccine policy said such plans could backfire, confusing the public, eroding confidence in any eventual vaccine and undermining the best strategy to end the pandemic, which has sickened nearly 7.5 million Americans and killed more than 210,000.

"Do you really want a situation where Texas, Alabama and Arkansas are making drastically different vaccine policies than New York, California and Massachusetts?" asked Dr. Saad Omer, an epidemiologist who leads the Yale Institute for Global Health.

Separate state vaccine reviews would be unprecedented and disruptive, and a robust regulatory process already exists, said Michael Osterholm, an epidemiologist and director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

"States should stay out of the vaccine review business," Osterholm said. "I think the Food and Drug Administration is doing their job right now. Unless there’s something that changes that, I do believe that they will be able to go ahead."

The administration has given reasons for states to worry. Trump has repeatedly signaled a desire for approval of a vaccine by the Nov. 3 election, arousing fears that he will steamroll the normal regulatory process.

The president wields "considerable power" over the FDA because it’s part of the executive branch of government, said Lawrence Gostin, faculty director of the O’Neill Institute for National and Global Health Law. The president nominates the FDA commissioner and can replace that official at any time.

Trump has already contradicted the advice of his own scientific advisers in order to promote unproven therapies to fight Covid-19. The FDA approved two treatments — hydroxychloroquine and convalescent plasma — without strong evidence of safety and efficacy after Trump pushed for the therapies to be widely available.

Late Monday, The New York Times reported that top White House officials planned to block FDA guidelines that would bolster requirements for emergency authorization of a Covid vaccine — because the new guidelines would almost certainly delay approval until after the election.

The White House’s actions undermine the agency, said Dr. Paul Offit, an infectious disease expert at Children’s Hospital of Philadelphia and a member of the FDA advisory committee on vaccines.

"Trump has perverted the FDA," Offit said. "He has scared people into thinking that normal systems aren’t in place there anymore."

But the FDA seems to be maintaining plans that would make it virtually impossible for a vaccine to be approved by Election Day.

Dr. Peter Marks, who heads the FDA division responsible for vaccine approval, has repeatedly said career scientists at the agency are working to ensure that political pressure isn’t a factor in any decision.

FDA reviewers are determined to "keep our hands over our ears to the noise that’s coming in from all sides and keep our eyes on the prize," Marks said Monday in a JAMA webinar.

On Tuesday, the FDA pushed back against White House interference by publishing stricter guidance for vaccine developers on its website. The document instructs vaccine companies to follow patients for two months after their last shot in order to give researchers more time to detect serious side effects and ensure the vaccine works.

For now, supporters of the normal regulatory process are pinning their hopes on two advisory groups of respected scientists who will evaluate vaccines for safety and efficacy and send their recommendations to federal agencies.

The FDA’s advisory group, known as VRBPAC, will review data submitted by the pharmaceutical companies and the agency for any vaccine. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, or ACIP, will weigh in on its use. Their recommendations aren’t binding, but the federal government has rarely contravened them.

Before jumping to independent reviews, states should allow ACIP and VRBPAC to do their jobs, said Dr. Marcus Plescia, chief medical officer of the Association of State and Territorial Health Officials. That’s the best defense against any political pressure, he said, and individual states likely wouldn’t have access to the data — or, perhaps, the expertise — to conduct their own reviews.

ACIP Chairman Dr. José Romero, who also is the chief medical officer for the Arkansas Department of Health, said the group has been meeting regularly since spring to discuss Covid vaccines and they’ve been able to proceed "in an unfettered fashion."

"I have not felt pressured by the CDC, other government agencies or pharmaceutical companies to arrive at any particular recommendation," he said.

Other safeguards are in place as well. Trump cannot simply override the FDA’s authority to approve drugs and vaccines, which comes from Congress.

"The president can influence the FDA, but it must be consistent with the FDA’s statutory mandate," Gostin said. "The White House may not, for example, direct the agency to ignore science or use a lower scientific standard."

Congress could sue the FDA for failing to follow its own standards, and a judge could issue a temporary restraining order blocking release of a Covid vaccine, Gostin said. Courts would require the FDA commissioner or health and human services secretary to have "valid, evidence-based reasons" for any decision.

"The commissioner or secretary may not act arbitrarily or according to political preferences alone," Gostin said.

Individual states could not overrule the FDA’s authorization or approval of a vaccine, but they could wield their power in other ways. States distribute vaccines through contracts with the CDC, noted Dr. Kelly Moore, associate director of immunization education for the Immunization Action Coalition. They could say, "’We will not place any orders until we’re sure,’" she said.

States probably could not prevent private companies, such as pharmacy chains, from distributing vaccines that are shipped directly to them. Pharmacies would likely sue any states that try to prevent them from distributing vaccines, Gostin said.

Although federal and state agencies play a crucial role in ensuring patient safety, they’re not the only entities looking out for patient interests, said Dr. Joshua Sharfstein, a former FDA deputy commissioner who is now a vice dean at the Johns Hopkins Bloomberg School of Public Health. Doctors and other medical providers won’t recommend a vaccine they don’t trust, he said.

"We have an entire health care system standing between politics and the patients," Sharfstein said. "I think doctors are going to be very concerned if a vaccine is rushed."

Even pharmaceutical companies that stand to profit from vaccines have a huge stake in protecting the integrity of the approval process. Nine rival vaccine makers took the unusual step last month of pledging not to release a Covid vaccine until it has been thoroughly tested for safety.

The bigger consideration, however, is how state-by-state vetting would affect consumer trust in a Covid vaccine — or any vaccine in the future, Plescia said. A recent KFF poll found 54% of Americans would not submit to a Covid vaccine authorized before Election Day.

"Are people going to mistrust the entire process?" he said. "We will get through Covid one way or another, but if we undermine confidence in public health, that would be a disaster."

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

*New* Article from physician e-news: Covid-19: Azithromycin Appears to Have No Benefit in Hospitalized Patients 10/7/2020 – Salynn Boyles, Contributing Writer, BreakingMED™

Reviewed By: Kevin Rodowicz, DO, Assistant Professor, St. Luke’s University/Temple University

Adding azithromycin to hydroxychloroquine was not associated with better outcomes among patients hospitalized with severe Covid-19 in a large, multicenter clinical trial from Brazil.

No benefit was shown for adding the widely prescribed antibiotic to standard care, which included hydroxychloroquine, in terms of clinical status and mortality (odds ratio, 1.36; 95% CI, 0.94-1.97; P=0.11) in the COALITION II trial.

The findings, published in The Lancet, "do not support the routine use of azithromycin in combination with hydroxychloroquine in patients with severe Covid-19," wrote researcher Remo Furtado, MD, of Hospital Israelita Albert Einstein, São Paulo, Brazil, and colleagues.

The trial results corroborate those of the companion COALITION I study, published in late July, which evaluated hydroxychloroquine with or without azithromycin in patients with mild-to-moderate Covid-19.

In that trial, no significant clinical difference was observed in outcomes among patients taking hydroxychloroquine, with and without azithromycin.

In an editorial published with the latest study, Catherine Oldenburg, PhD, and Thuy Doan, MD, PhD, of the University of California, San Francisco, wrote that COALITION I and II suggest no benefit for azithromycin in patients whose disease has progressed to the point that they require hospitalization.

Oldenburg and Doan are currently recruiting patients for a telemedicine-based trial designed to evaluate the efficacy of a single dose of azithromycin for preventing Covid-19 progression in patients with a recent positive SARS-CoV-2 diagnosis who are not hospitalized.

"Because azithromycin is currently the most commonly prescribed outpatient therapy for Covid-19, establishing whether azithromycin is helpful earlier in the disease course is an important research priority," they wrote. "If azithromycin does not have a role in the treatment of Covid-19, avoiding its use would reduce unnecessary antibiotic consumption."

The COALITION II open-label study — conducted at 57 treatment centers in Brazil — included adult patients hospitalized for Covid-19 who had symptom onset no more than 14 days prior to recruitment and had evidence of severe disease, defined by need for supplemental oxygen of more than 4 L/min flow; use of high-flow nasal cannula; use of non-invasive positive-pressure ventilation; or use of mechanical ventilation.

Patients were randomly assigned (1:1) to azithromycin (500 mg via oral, nasogastric, or intravenous administration once daily for 10 days) plus standard of care or to standard of care without macrolides.

All patients received hydroxychloroquine (400 mg twice daily for 10 days), which was standard protocol in Brazil at the time of the study.

The primary outcome was clinical status at day 15 after randomization, which was assessed by a treatment-blinded committee evaluating a six-point ordinal scale, with levels ranging from 1 to 6 and higher scores indicating a worse condition (with odds ratio [OR] greater than 1.00 favoring the control group).

A total of 447 patients were enrolled from March 28 to May 19, and Covid-19 was confirmed in 397 patients who constituted the modified intention-to-treat (mITT) population (214 were assigned to the azithromycin group and 183 to the control group).

In the mITT population, the primary endpoint was not significantly different between the azithromycin and control groups and rates of adverse events, including clinically relevant ventricular arrhythmias, resuscitated cardiac arrest, acute kidney failure, and corrected QT interval prolongation, were not significantly different between the two groups.

There was no evidence of a difference in outcomes by sex, but a prespecified subgroup analysis suggesting worse clinical status at 15 days in younger patients treated with azithromycin.

In their editorial, Oldenburg and Doan wrote that a major strength of COALITION II was the randomization, "which eliminated the confounding by indication inherent in observational analysis."

The study’s open-label design could be seen as a limitation, while the use of outcome adjudicators blinded to the treatment was a strength, they wrote.

"Although masking outcome assessors is an important step toward minimizing bias, open-label designs are more prone to bias than fully masked placebo-controlled trials," they wrote. "With the use of a placebo, treating physicians, patients and others involved in patient care are unaware of the patient’s treatment assignment. Differences in patient care between groups could influence outcomes, even with the use of masked outcome assessors."

The administration of azithromycin with hydroxychloroquine, which was given as standard of care at the time, limit the evaluation of azithromycin alone as a treatment for Covid-19, they wrote.

"Given the results of trials assessing hydroxychloroquine in Covid-19, it is unlikely that hydroxychloroquine has any effect on disease progression, but its use might bias estimates toward the null compared with treatment with azithromycin alone."

They concluded that placebo-controlled trials in hospitalized patients with Covid-19 and in patients with mild-to-moderate disease who are not hospitalized "would strengthen the evidence and provide a comprehensive understanding of the role of azithromycin in Covid-19."

Furtado RHM, et al "Azithromycin in addition to standard of care versus standard or care alone in the treatment of patients admitted to the hospital with severe Covid-19 in Brazil (COALITION II): a randomized clinical trial," The Lancet 2020; 396: 959–967.

Oldenburg CE, Doan T "Azithromycin for severe Covid-19" The Lancet 2020; 396: 936-937.

*New* Article from physician e-news: AMA Updates CPT Codes for Covid-19 Care 10/7/2020 – John McKenna, Associate Editor, BreakingMED 

The American Medical Association announced the addition of two new Current Procedural Terminology (CPT) codes for tests that simultaneously detect Covid-19 and influenza A/B, as well as code revisions to clarify proper reporting for antigen tests.

These updates, which were approved for immediate use by the CPT Editorial Panel, are intended to assist clinicians in correctly reporting medical services connected to the ongoing Covid-19 pandemic.

"Two of the newly approved codes report nucleic acid assays that allow a single test to simultaneously detect the novel coronavirus and a combination of common viral infectious agents, including influenza A/B and respiratory syncytial virus," said AMA President Susan R. Bailey, MD, in a statement. "Concurrent detection promises to conserve important testing resources, allowing for ongoing surveillance of influenza while testing for the novel coronavirus."

The AMA provided these new CPT codes, as well as their descriptions, in its announcement:

  • 87636: "Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [Covid-19]) and influenza virus types A and B, multiplex amplified probe technique."
  • 87637: "Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [Covid-19]), influenza virus types A and B, and respiratory syncytial virus, multiplex amplified probe technique."

The CPT Editorial Panel also made changes to codes "ranging from 87301 to 87430, the AMA reported, removing the term "multi-step method" from code descriptors to distinguish between antigen tests that are read by a machine and those that can be visually interpreted.

This revision, the AMA noted, "affects the newly developed descriptor for CPT code 87426" and led to the creation of a new category I code—87811—for reporting antigen detection using an immunoassay interpreted via direct visual observation:

  • 87426: "Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; severe acute respiratory syndrome coronavirus (e.g., SARS-CoV, SARS-CoV-2 [Covid-19])."
  • 87811: "Infectious agent antigen detection by immunoassay with direct optical (i.e., visual) observation; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [Covid-19])."

Short and medium descriptors for CPT codes 87636, 87637, 87426, and 87811 are available on the AMA’s website, "along with several other recent modifications to the CPT code set that have helped streamline the public heqlth response to the SARS-CoV-2 virus and the Covid-19 disease," the AMA wrote.

*New* Article from physician e-news: Covid-19: Lopinavir-Ritonavir Combo Falls Short—Again 10/6/2020 – Shalmali Pal, Contributing Writer, BreakingMED™
Reviewed By: Kevin Rodowicz, DO, Assistant Professor, St. Luke’s University/Temple University

Lopinavir-ritonavir (Kaletra) failed to hasten recovery or reduce mortality for inpatients with Covid-19, according to results from the RECOVERY trial.

Mortality at 28 days was 23% among the hospitalized Covid-19 patients randomized to the HIV protease inhibitor plus usual care versus 22% in the usual care-alone group (rate ratio 1.03, 95% CI 0.91-1.17), reported Peter W. Horby, MD, PhD, and Martin J. Landray, MBChB, PhD, both of the RECOVERY Central Coordinating Office in Oxford, England, and co-authors.

Additionally, there were no differences in secondary endpoints, including time to hospital discharge for survivors and a composite endpoint of invasive mechanical ventilation (IMV) or death for those who were not intubated at baseline, they wrote in the Lancet.

These findings held true in prespecified subgroups of sex, age, duration of illness, degree of baseline respiratory support, and predicted mortality risk, the authors noted.

"Many clinical care guidelines have recommended lopinavir-ritonavir for treatment of patients admitted to hospital with Covid-19. These guidelines should be updated," they stated.

With over 5,000 patients, these results offer "a more solid evidence base regarding possible lopinavir-ritonavir treatment effects," versus findings from a study out of Wuhan, China or those from the ongoing World Health Organization Solidarity trial, noted Bin Cao, MD, PhD, of China-Japan Friendship Hospital in Beijing, and Frederick Hayden, MD, of the University of Virginia School of Medicine in Charlottesville, in a comment accompanying the study.

They pointed out that "Treatment of Covid-19 with lopinavir-ritonavir has been recommended as a first-line or second line in many countries," but "The results from the RECOVERY trial show that lopinavir-ritonavir monotherapy is not an effective treatment for patients admitted to hospital with Covid-19." In July 2020, the NIH recommended against using lopinavir-ritonavir for hospitalized Covid-19 patients outside of clinical trials.

Still, Cao and Hayden noted that early antiviral treatment or post-exposure prophylaxis in high-risk populations may still be viable for mild cases of Covid-19.

"Given the efficient replication of SARS-CoV-2 shortly after infection and the association between mortality and viral RNA loads at diagnosis, it is possible that early use of sufficiently potent antiviral drugs would be an important determining factor in clinical outcomes, although few early intervention trials have been completed," they wrote, adding that antiviral and immunomodulator combinations should be studied because monotherapy may be insufficient for moderately to severely ill Covid-19 patients in the hospital.

RECOVERY is a U.K.-based pragmatic trial in which hospitalized patients with SARS-CoV are randomized to various open-label treatments. Interim results from RECOVERY in March 2020 demonstrated a mortality benefit in Covid-19 with dexamethasone, the steroid that President Trump is currently receiving.

Other agents being investigated in RECOVERY are tocilizumab (Actemra), convalescent plasma, REGN-CoV2 combination monoclonal antibodies, and azithromycin. The trial’s hydroxychloroquine arm was terminated after showing that the immunosuppresant was not tied to reductions in 28-day mortality but was instead linked with an increased risk of progressing to invasive mechanical ventilation or death.

For the current study, 1,616 patients (mean age 66.2 years; majority white men) were randomly allocated to receive lopinavir-ritonavir and 3,424 patients were assigned to receive usual care from March through June 2020. The study drug dosing regimen consisted of oral 400 mg and 100 mg, respectively, for 10 days or until discharge, or to one of the other RECOVERY treatment groups.

"At randomization, about a quarter of patients had no ventilatory support, most were receiving oxygen only, and a very small proportion were on invasive mechanical ventilation," the authors wrote.

Horby, Landry, and co-authors reported the following for the secondary outcomes:

  • Time to hospital discharge for survivors: median 11 days for both study groups.
  • Time until discharge alive from hospital within 28 days: RR 0.98 (95% CI 0.91-1.05).
  • IMV or death for those without baseline intubation: RR 1.09 (95% CI 0.99-1.20).
  • Limitations of the current study included a small number of intubated patients, "as there were difficulties in administering treatment to patients who could not swallow," according to the authors. In addition, "It is unclear whether the dose of lopinavir-ritonavir we used achieved adequate SARS-CoV-2 inhibitory concentrations in the lungs," they explained, citing a pharmacology study from August 2020 that stated "The doses [ of lopinavir-ritonavir] required to provide optimal inhibition are obviously impracticable due to unacceptable risk of toxicity."

Nonetheless, the authors emphasized that "lopinavir-ritonavir does not improve clinical outcomes for patients admitted to hospital with Covid-19."

Whether clinicians will accept the RECOVERY findings as the final word on this treatment regimen is another matter. In multiple letters to the editor in the May 2020 New England Journal of Medicine, physicians took issue with results from the Wuhan study, performed by Cao and colleagues, arguing that "the trial was statistically underpowered to show this outcome [time until clinical improvement];" that "Antiviral drugs are most effective when they are administered early in an infection, yet the patients in this trial underwent randomization a median of 13 days after disease onset;" that "patients who received lopinavir-ritonavir [had] a shorter stay by 5 days in the intensive care unit;" and that "Lopinavir-ritonavir… is available for immediate clinical use in many countries. Because there currently are no approved treatments for Covid-19… we should not yet abandon lopinavir-ritonavir… pending completion of the World Health Organization SOLIDARITY trial."

Whether developer AbbVie will continue to support the drug combo in Covid-19 care after RECOVERY results is unknown. In June 2020, after the disappointing Wuhan results, the company teamed up with Harbour BioMed, Utrecht University, and Erasmus Medical Center, both in the Netherlands, to develop a new antibody to prevent and treat Covid-19, according to Fierce Biotech.

RECOVERY Collaborative Group "Lopinavir-ritonavir in patients admitted to hospital with Covid-19 (RECOVERY): a randomised, controlled, open-label, platform trial" The Lancet 2020; DOI: 10.1016/S0140-6736(20)32013-4.

Cao B, Hayden FG "Antiviral monotherapy for hospitalized patients with Covid-19 is not enough" The Lancet 2020; DOI: 10.1016/S0140-6736(20)32013-4.

*New* Article from physician e-news: Easier-to-Use Coronavirus Saliva Tests Start to Catch On 10/6/2020 – David Tuller, Kaiser Health News

As the coronavirus pandemic broke out across the country, health care providers and scientists relied on the standard method for detecting respiratory viruses: sticking a long swab deep into the nose to get a sample. The obstacles to implementing such testing on a mass scale quickly became clear.

Among them: Many people were wary of the unpleasant procedure, called a nasopharyngeal swab. It can be performed only by trained health workers, putting them at risk of infection and adding costs. And the swabs and chemicals needed to test for the virus almost immediately were in short supply.

Some places, like Los Angeles County, moved early to self-collected oral swabs of saliva and sputum, with the process supervised at drive-thru testing sites by trained personnel swathed in protective gear. Meanwhile, researchers began investigating other cheaper, simpler alternatives to the tried-and-true approach — including dribbling saliva into a test tube.

But the transition has not been immediate. Regulators and scientists are generally cautious about new, unproven technologies and have an understandable bias toward well-established protocols.

"Saliva is not a traditional diagnostic fluid," said Yale microbiologist Anne Wyllie, part of a team whose saliva-based test, called SalivaDirect, received emergency use authorization from the Food and Drug Administration in August. "When we were hit by a virus that came out of nowhere, we had to respond with the tools that were available."

Eight months into the pandemic, the move toward saliva screening is gaining traction, with tens of thousands of people across the country undergoing such testing daily. However, saliva tests still represented only a small percentage of the more than 900,000 tests conducted daily on average at the end of September.

Yale is providing its protocol on an open-source basis and recently designated laboratories in Minnesota, Florida and New York as capable of performing the test. Besides the Yale test, the FDA has authorized emergency use of several others, including versions developed at Rutgers University, the University of South Carolina and SUNY Upstate Medical University. A further advance, an at-home saliva testcould be headed for FDA authorization, too.

Since the start of the pandemic, the Trump administration’s approach to testing has been hampered by missteps and controversy. As a key health agency during an unprecedented emergency, the FDA’s effectiveness relies on public trust in how it balances the need for speed in authorizing innovative products, like saliva tests and vaccines, with ensuring safety and effectiveness, said Ann Keller, an associate professor of health policy at the University of California-Berkeley.

"You obviously want to get new tests into the mix quickly in order to address the emergency, but you still need to uphold your standards," Keller said. The White House’s public pressure on the FDA has complicated the agency’s efforts by undermining its credibility and independence, she said.

Respiratory viruses colonize areas inside the nasal cavity and at the back of the throat. Besides the nasopharyngeal approach, nasal samples obtained with shorter and less invasive swabs have proven effective for the coronavirus and have become widely adopted, although they also generally require a health care worker’s involvement. The millions of rapid tests that will be distributed across the country, per a recent White House announcement, rely on nasal swabs.

In the early months of the pandemic, some studies reported significant levels of the virus in oral secretions. In a Hong Kong study published in February, for example, the virus was found in the saliva of 11 of 12 patients with confirmed coronavirus infection.

In Los Angeles, which began using the oral swab test in late March, more than 10,000 samples are collected per day, said Fred Turner, chief executive of Curative, the company that developed it.

Turner sees an advantage to the swabbing strategy. The self-swab procedure takes only 20 to 30 seconds, while producing enough saliva for testing can take people two to three minutes, and sometimes longer, he said. "That might not sound like much difference," Turner said, "but it is when you’re trying to push 5,000 people through a test site."

Curative’s three labs process tens of thousands of tests from jurisdictions across the country in addition to L.A., Turner said. A test developed at SUNY Upstate Medical University, which is expected to become available at state labs around New York, also uses an oral swab.

For the Curative test, a health care worker is supposed to oversee the sample collection —reminding people to cough to bring up fluids, for example. When investigators at the University of Illinois launched what they called a "Manhattan Project" to develop a saliva test by mid-June, they hoped to make it possible for people to visit a collection site, drool into a test tube, seal it and drop it off without the aid of a health care worker.

The university is now testing more than 10,000 people a day at its three campuses and is seeking to expand access to communities across the state and country, said chemistry professor Paul Hergenrother, who led the research team. Like the similar Yale test, it is being made freely available to other laboratories. The University of Notre Dame, in Indiana, recently adopted it.

Like tests using nasopharyngeal and other kinds of nasal swabs, these saliva tests are based on PCR technology, which amplifies small amounts of viral genetic material to facilitate detection. Both the Yale and University of Illinois tests have managed to simplify the process by eliminating a standard intermediate step: the extraction of viral RNA. Their protocols also don’t require viral transport media, or VTM — the chemicals generally used to stabilize the samples after collection.

"You don’t need swabs, you don’t need health care workers, you don’t need VTM, and you don’t need RNA isolation kits," Hergenrother said.

In correspondence published in the New England Journal of Medicine, the Yale team reported detecting more viral RNA in saliva specimens than in nasopharyngeal ones, with a higher proportion of the saliva tests showing positive results for up to 10 days after initial diagnosis.

The National Basketball Association provided $500,000 in support for the Yale project, said David Weiss, the NBA’s senior vice president for player matters. He said the Yale team’s decision to eliminate the process of RNA extraction, which separates the genetic material from other substances that could complicate detection, involved trade-offs but did not compromise the value of the test.

"Any molecular test that has an RNA extraction step is almost by definition going to be more sensitive, but it will also be more expensive and take longer and use supplies that are in shorter supply," he said. "If we’re trying to look at surveillance testing to open up schools and nursing homes, a test that’s still very sensitive and a lot cheaper is an important innovation."

Prices for coronavirus tests vary widely, running upward of $100. Tests based on the Yale or University of Illinois protocols, which require only inexpensive materials, could be available for as little as $10. The Curative testing service, which includes collection and transportation of samples as well as the laboratory component, averages around $150 per test depending on volume, said Clayton Kazan, chief medical director of the L.A. County Fire Department, which uses the tests.

Despite the advances in sample collection, tests using PCR — polymerase chain reaction — technology still require laboratory processing. Researchers have been investigating other approaches, including saliva-based antigen tests, that could be self-administered at home and would provide immediate results. (While PCR can detect coronavirus genetic material, antigen tests look for viral proteins that can signify a current infection.)

At least one company has announced it is seeking emergency use authorization for a saliva antigen test, although two others have dropped plans to develop their own versions as infeasible, according to The New York Times. Meanwhile, scientists at Columbia University, the University of Wisconsin and elsewhere are investigating the use of saliva with other kinds of rapid-test technologies.

"There’s tons of interest" in an at-home saliva test, noted Yvonne Maldonado, chief of pediatric infectious diseases at Stanford University School of Medicine.

"People really do want to get that pregnancy-type kit out there," she said. "You could basically send people a little packet with little strips, and you pull off a strip every day and put in under your tongue."

This KHN story first published on California Healthline, a service of the California Health Care Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

*New* Article from physician e-news: ACP Backs Remdesivir Tx for Patients with Covid-19 10/5/2020 – John McKenna, Associate Editor, BreakingMED™
Reviewed By: Kevin Rodowicz, DO, Assistant Professor, St. Luke’s University/Temple University

The American College of Physicians released new Rapid Living Practice Points backing the use of the antiviral remdesivir for patients infected with Covid-19.

In its Practice Points, the ACP noted that evidence indicates "a net benefit for remdesivir in patients with moderate Covid-19 and suggests that a shorter treatment period (5 days) is as effective as a longer one (10 days), with no increase in harms."

Based on this evidence, the ACP issued the following recommendations:

  • "Use remdesivir for 5 days as a treatment for patients with moderate Covid-19.
  • "Use remdesivir for 5 days as a treatment for patients with severe Covid-19 who do not require mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
  • "Consider extending the use of remdesivir to 10 days in patients with severe Covid-19 requiring mechanical ventilation or ECMO within a 5-day course."

"ACP’s Living Practice Points show that evidence comparing 5-day vs. 10-day course indicated that a 5-day course of remdesivir may slightly reduce mortality and may slightly increase clinical improvement compared with a 10-day course," the ACP explained. "Evidence for potential harms showed that a 5-day course may result in slightly fewer adverse events (any) compared with a 10-day course, although the shorter course may not result in fewer serious adverse events."

The physicians’ organization pointed out that there is no evidence that either course of remdesivir has any effect on other critical outcomes such as recovery or hospital length of stay, or on important outcomes, including time to recovery, time to clinical improvement, invasive mechanical ventilation/ECMO, and non-serious adverse events.

"With remdesivir there is evidence of benefit with shorter duration treatment for patients with both moderate or severe COVID-19," said Jacqueline W. Fincher, MD, ACP President, in a statement, "which is positive news in the search for treatments of patients with Covid-19. However, significant evidence gaps remain and additional rigorous studies are needed to assess the benefits and harms of using remdesivir to treat patients with Covid-19."

The ACP’s Practice Points suggested that future studies assessing use of remdesivir for Covid-19 should focus on treatment duration by symptom severity and assess clinical outcomes such as respiratory failure.

*New* Article from physician e-news: Covid-19: Despite Telemedicine Surge, Primary Care Visits Fall 10/2/2020 – Paul Smyth, MD, Contributing Writer, BreakingMED™
Reviewed By: Kevin Rodowicz, DO, Assistant Professor, St. Luke’s University/Temple University

Despite the surge in telemedicine, the number of primary care visits has fallen since the Covid-19 public health emergency — and so has screening for cardiovascular risk factors, according to an analysis of serial cross-sectional data.

Primary care consultations declined by 21.4% percent during the second quarter of 2020, compared with average second-quarter volumes in 2018 and 2019, reported G. Caleb Alexander, MD, MS, of Johns Hopkins University, and co-authors, in JAMA Network Open.

This occurred despite a huge rise in telemedicine use — both audiovisual and audio-only visits— which jumped from 1.1% of total visits in Q2 2018-2019 to 35.3% in Q2 2020.

The content of virtual visits also differed from that of office-based encounters.

"The pandemic has been associated with substantial decreases in primary care delivery, despite large increases in the use of telemedicine, which accounted for fewer than 2% of primary care visits during 2019 yet more than 35% of visits during Q2 of 2020," Alexander and colleagues wrote. "Evaluations of cardiovascular risk factors such as blood pressure and cholesterol have decreased, owing to fewer total visits and less frequent assessment during telemedicine encounters."

"We did not find substantial differences in telemedicine use by payer type, and, contrary to our expectations and evidence of a digital divide, we did not find evidence of a racial disparity in telemedicine use when examining the frequency of telemedicine encounters as a proportion of a patient visits among Black versus white individuals," they added.

For the eight quarters from Jan. 1, 2018 and Dec. 31, 2019, mean quarterly primary care visits were 125.8 million, and 92.9% of those were in the office. In Q1 2020, the total number of primary care encounters decreased to 117.9 million. By Q2 2020, they fell to 99.3 million visits.

Comparing Q2 2020 data with Q2 2018-2019 figures:

  • Overall primary care visits decreased by 21.4% (27.0 million visits).
  • Office-based visits decreased by 50.2% (59.1 million visits).
  • Telemedicine visits increased from 1.1% (1.4 million) of total visits to 35.3% (35.0 million visits).
  • Blood pressure assessment decreased by 50.1% (9.6% of telemedicine and 69.7% of office visits, P < 0.001).
  • Cholesterol level assessment decreased by 36.9% (13.5% of telemedicine and 21.5% of office visits, < 0.001).
  • New medication visits decreased by 26.0% (14.1 million visits).

During Q1 and Q2 of 2020, telemedicine use occurred at similar rates among white and Black patients (19.3% versus 20.5% of visits, respectively), but varied by region (15.1% of visits in the East North Central region and 26.8% of visits in the Pacific region). Telemedicine adoption was not correlated with regional Covid-19 burden.

Alexander and co-researchers used the National Disease and Therapeutic Index, a nationally representative audit of outpatient practice from the health care technology company IQVIA, to develop their analysis.

In an accompanying editorial, Lisa Chew, MD, MPH, of the University of Washington in Seattle, and coauthors wrote, "Our experience in the Pacific Northwest, where Alexander et al found the sharpest increase in telehealth adoption, leads us to predict far more consequences for health equity than were revealed in their analysis. While we were glad to see similar rates of telehealth care provided to white and Black patients in their sample, our local patterns suggest a story of differential access to virtual care."

In their region, audiovisual telemedicine adoption was lower in clinics for homeless people (0.4%), patients with limited English proficiency (2.6%), and a racially diverse safety-net population (7.3%), they noted.

"These clinics had the same rapid expansion of access to telemedicine support and technology as general medicine clinics within our system, where 1,775 of 5,828 visits (30.5%) were conducted by telemedicine during the same period," they wrote. "The most common barrier we encounter is lack of access to the necessary technology."

2018 systematic review identified practice-level barriers, including technically challenged staff, resistance to change, cost, reimbursement, and patient age and education level, concluding that "the top barriers are technology-specific and could be overcome through training, change-management techniques, and alternating delivery by telemedicine and personal patient-to-provider interaction."

At the national level, regulatory and commercial issues, along with structural and social factors, affect rates of telemedicine adoption. As with health care in general, questions of fairness and disparity have become a focus of interest.

"Nouri et al recently found that patients with socioeconomic disadvantage were significantly underserved by telemedicine visits in March 2020," the editorialists noted. "They described lower rates of telemedicine uptake among patients who were non-white, were older, had low English proficiency, and lacked commercial insurance."

Limitations include those of cross-sectional study, particularly during a public health emergency of ongoing, rapid change. Racial distinctions were limited to Black and white—"a limited window through which to understand how telemedicine adoption may vary across different populations," Alexander and co-authors acknowledged.

Clinical parameters in the study (new medication visits and checks of blood pressure and cholesterol) are an important but limited selection from many possible measures. The study defined telemedicine as audio or audiovisual, but stricter audiovisual-only definitions are used in some research, policy, and payment settings.

Alexander GC, et al "Use and content of primary care office-based vs telemedicine care visits during the COVID-19 pandemic in the U.S." JAMA Network Open 2020; DOI:10.1001/jamanetworkopen.2020.21476.

Chew L, et al "The pandemic of health care inequity" JAMA Network Open 2020; DOI:10.1001/jamanetworkopen.2020.21767.

 

*New* Article from physician e-news: NFID Panelists Warn of Covid-19/Flu ’Twindemic’, Urge Flu Vax 10/1/2020 – John McKenna, Associate Editor, BreakingMED™

A panel of infectious disease experts went live at the virtual 2020 National Foundation for Infectious Diseases (NFID) Influenza/Pneumococcal Disease News Conference to review outcomes from last year’s flu season, discuss the ramification of Covid-19 for this year’s season, and reiterate their annual message — "get your annual flu vaccine now."

According to the CDC, the 2019-2020 flu season resulted in approximately 38 million illnesses, 18 million flu-related health care visits, 400,000 flu-related hospitalizations, and 22,000 deaths — and kids were hit particularly hard due to the spread of influenza B viruses that kicked of the season, a development that William Schaffner, MD, NFID Medical Director and professor of Preventive Medicine and Infectious Diseases at Vanderbilt Medical Center in Nashville, called "unprecedented" in an interview with BreakingMED.

Schaffner was the moderator for this year’s NFID conference, and he was joined by three panelists: Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases and one of the public faces of the U.S. Covid-19 response; Federico Asch, MD, FACC, FASE, director of the Echocardiography Core Lab at MedStar Health Research Institute and Associate Professor of Medicine at Georgetown University; and Patricia Whitley-Williams, NFID President and professor of Pediatrics and associate dean for Inclusion and Diversity at Rutgers Robert Wood Johnson Medical School.

Schaffner kicked off this year’s conference by noting the sorry state of flu vaccine coverage during the 2019-2020 flu season. According to the CDC, 52% of people in the U.S. received a flu vaccine last year, including 48% of adults and around 64% of children — a small uptick in coverage compared to the 45% vaccination rate among U.S. adults in the 2018-2019 season, but a far cry short of the CDC recommendation that everyone ages 6 months and older receive the shot.

And this year, Schaffner noted, there’s also Covid-19 to contend with.

Combating a Covid-19/Flu ’Twindemic’

"As we look to the months ahead, the scary reality is that we could face a ’twindemic’ of Covid-19 and influenza circulating simultaneously," Schaffner said. "The two viruses share similar symptoms — people with Covid-19 may assume they have the flu, and vice versa." But will this frightening fact lead to additional vaccine uptake this flu season?

During his keynote presentation, Fauci said that Covid-19 is "truly a transforming pandemic of historic nature, and we’re not through with it yet. In fact, there’s considerable concern as we enter the fall and the winter months and into the flu season, that we’ll have that dreaded overlap of two respiratory borne diseases, namely influenza and Covid-19."

Schaffner told BreakingMED that the potential confluence of Covid-19 and influenza will likely cause a great deal of confusion among the U.S. public as patients and physicians alike struggle to distinguish the two illnesses. "They’re both respiratory infections, and the array of symptoms that patients have overlap very substantially—not completely, but very substantially," Schaffner said, adding that the testing modalities for influenza and Covid-19 are both far from perfect. "Covid [testing] is very specific, but it takes a while for the test results to come back —not very useful, at the moment," he said. "We have point-of-care tests for flu, but they’re not very sensitive; particularly in adults, you can have a lot of false negative tests. They work better in children. So, the testing we have will help us up to a point, but only up to a point."

And that is why, Fauci noted, it is vital to make use of "the ability — which we have — of medically avoiding at least one of those and, by public health measures, both of those."

Fauci shared a series of overlapping symptoms that will make distinguishing flu from Covid-19, and vice versa, a "diagnostic challenge," including:

  • Fever or feeling feverish/chills.
  • Cough.
  • Shortness of breath or difficulty breathing.
  • Fatigue.
  • Sore throat.
  • Runny or stuffy nose.
  • Muscle pain or body aches.
  • Headache.
  • Vomiting and diarrhea.

Fortunately, Fauci pointed out that steps for fighting the flu and Covid-19 also significantly overlap. He encouraged people to wear masks or face coverings in public, maintain physical distance of at least 6 feet, avoid crowds, gather outdoors when possible, wash hands frequently, avoid touching eyes, nose, and mouth, clean and disinfect surfaces, stay home when sick, and take antiviral medications if they’re prescribed by your doctor.

And, most importantly, he encouraged people to get the flu vaccine "to protect yourselves, your loved ones, and your community."

Fauci pointed to the Southern Hemisphere, and particularly Australia and New Zealand, as a model for how to handle the concurrent Covid-19 pandemic and flu season. "They did so many of these things… [and] they had a very, very light flu season… hopefully, together with the flu vaccine, if we do what’s on this slide, we’ll have the same thing."

Schaffner added that the Covid-19 pandemic might impact the ability of people working from home to get the flu vaccine.

"Many people are now still working from home," he told BreakingMED. "So, they won’t be able to take advantage of the flu vaccine programs that employers have in the workplace, and they’re going to have to seek out the vaccine on their own. So, it’s important that we encourage and reassure people while we try to motivate them and stimulate them to go out and get the vaccine."

As for people who are worried about running out to their physician to get their flu vaccine, Schaffner encouraged them to call ahead to their health care provider to see whether or not their clinic has strategies in place for rapid and safe vaccination. And, if people should become ill, he strongly urged them to call or email their physician rather than going into the clinic and spreading their illness in the waiting room.

And what impact might the politization of the U.S. Covid-19 response have on the upcoming flu season?

Schaffner told BreakingMED that it "makes our response… much more difficult because it interferes and confuses the public health messages. And it’s quite clear the public is very confused about Covid. Because there’s been a lack of national leadership, we now have this crazy quilt of different responses, according to which state your in — and even within states there are differences; what we do in Nashville is different than what’s happening in the counties around us. That doesn’t make any public health sense, but it’s really driven by politics rather than the epidemiology of Covid, or… the epidemiology of influenza.

"I mean, we recently passed 200,000 deaths in the United States," he continued. "I mean, that’s stunning — a really bad flu season, two years ago, was 80,000 deaths, and we’ve already gone way beyond that with Covid. But there are people out there who really don’t ’believe’ in Covid, who think it’s a hoax, or overblown. It’s hard to get to those folks because of the political coloration that the response to Covid has taken. It makes it very difficult.

"I would be very surprised if everyone in our national leadership got vaccinated against influenza, and let everybody know that they were getting vaccinated against influenza," he said. "That’s what we would need — I don’t think we’re going to get that."

And The Survey Says?
Leadership aside, to find out what U.S. adults are thinking about influenza and pneumococcal disease vaccination in the context of the Covid-19 pandemic, the NFID commissioned a survey — and the results, Schaffner noted, were "both hopeful, and also concerning."

According to the NFID-commissioned survey — currently available on the NFID’s website — "Overall, most U.S. adults believe vaccination is the best protection against flu, but many do not plan to get vaccinated during the 2020-2021 flu season."

The survey, which was conducted by the National Opinion Research Center (NORC) at the University of Chicago from Aug. 17 to 19 and which included 1,000 complete responses (897 via web and 103 via phone), found that while 68% of U.S. adults agree that flu vaccination is the best preventive measure against flu-related deaths and hospitalizations, only 59% of respondents actually plan to get vaccinated this year, while 15% were not sure — "a slight increase from the survey we commissioned last year," Schaffner noted, "but we still have a very long way to go."

The top reasons cited by those who were unsure or who do not plan to get the flu vaccine included:

  • 34% do not think the flu vaccines work very well — a large drop from 51% the previous year, which suggests that messaging from the health care community "around the benefits of partial protection is working," Schaffner noted. "We keep needing to hammer that point home."
  • 32% said they never get the flu.
  • 29% are concerned about side effects from the vaccine with 22% concerned the vaccine will give them the flu.
  • 17% are concerned about potential Covid-19 exposure if they go out to get the flu vaccine.

In addition, 22% of respondents who are at high risk for flu-related complications said they don’t plan on receiving the vaccine. And, while 59% of white adults and 65% of Hispanic adults plan to get the vaccine, 62% of Black adults said they were not sure or were not getting the vaccine.

The survey also found that, while U.S. adults are concerned about contracting Covid-19, they are not nearly as afraid of the flu: 46% of respondents reported being "extremely worried" about Covid-19 infection, while only 23% were similarly worried about the flu. An additional 46% of respondents reported concern about being infected with Covid-19 and flu simultaneously, with Black (61%) and Hispanic adults (53%) reporting the greatest concern.

Notably, 28% of respondents said the Covid-19 pandemic makes them more likely to seek out the flu vaccine.

The survey also revealed the troubling fact that 51% of adults who are at higher risk for pneumococcal disease, a potentially dangerous complication of the flu, reported that they have not been advised to get a pneumococcal vaccine. In fact, among adults age 65 years and older and those with underlying conditions, who are at the highest risk, 46% were not familiar with pneumococcal disease, 65% were not sure of their vaccination status or had not received a vaccine, and 89% of those who have not received it were either unsure or do not plan to receive the vaccine.

"There’s a gap we need to fill," Schaffner said.

Comorbidities, Disparities, and Pediatric Vaccinations
Another major focus of this year’s conference was the prevention of flu among patients with underlying medical conditions, overcoming racial disparities in health care, and improving flu vaccination among U.S. kids.

In his presentation, Asch pointed out that last flu season, 93% of adults hospitalized with the flu had at least one reported underlying condition that put them at higher risk for complications — typically diabetes, cardiovascular disease, obesity, and chronic lung disease. And, he noted, the Covid-19 pandemic will complicate the flu season for this population, as most patients who are at high risk for complications from one virus are also at risk from the other.

"Flu can exacerbate underlying conditions and lead to life-threatening complications like heart attack, stroke, permanent physical decline, pneumonia, hospitalizations, and even death" Ache said. "Patients with diabetes and heart disease are most vulnerable and need the added protection to their immune system." He pointed to recent studies which found that adults with heart disease are six times more likely to suffer a heart attack within 7 days of contracting the flu; in addition, the risk of flu-related hospitalization for adults with diabetes is six times higher, and this population is three times more likely to die due to flu-related complications.

"Bottom line, prevention through annual flu vaccination must be a part of overall disease management for older adults and for patients with chronic health conditions — and it is just as important as eating a balanced diet, quitting smoking, getting more exercise, or even being compliant with medication," Asch said. "The benefit of annual flu vaccination cannot be understated, because we know it lowers rates of serious infection, hospitalization, cardiovascular events, and death."

Asch also took a moment to address disparities in vaccine coverage among communities of color: "Sadly, complications from pneumonia and influenza combined are a leading cause of death among Hispanics. And yet vaccination coverage remains particularly low among this population; for the 2019-2020 flu season, vaccination coverage among Hispanic adults was only 38.3%… improving access to and acceptance of flu vaccine among communities of color and Hispanics must be part of our national strategy to prevent illness and reduce stress to the U.S. healthcare system as they fight flu and Covid-19."

Whitley-Williams also took on the topic of disparities in flu coverage among non-white racial groups, noting that "officially, non-Hispanic Black children have lower flu vaccination rates than children in all other racial and ethnic groups." She added that the finding in the NFID survey that Black adults are more worried about contracting Covid-19 and flu at the same time makes sense, given that Black adults are more likely to be hospitalized and die from both Covid-19 and the flu.

"We know that there are multiple variables at play here in communities of color," she said, "including, but certainly not limited to, unconscious bias, institutional racism, distrust of the healthcare system, and vaccine hesitancy. Despite these hurdles, we cannot become complacent in our attempts to drive change. Now is the time for change — now is the time for everyone to get a flu vaccine."

Whitley-Williams also noted that the conjunction of Covid-19 and flu will likely have an impact on kids as they transition back to in-person schooling. "As you know, children are super-spreaders of flu, as they are other respiratory viruses, but they do pass on more of the flu virus for longer periods of time compared to adults," potentially bringing illness home to their parents, grandparents, neighbors, and friends. "I still love the kids, though," she quipped.

While Whitley-Williams acknowledged that it is good news that pediatric flu vaccination rates were 63.8% for last year’s flu season, she argued that this is "not nearly good enough," pointing out that the 2019-2020 flu season led to a total of 189 pediatric flu-related deaths — and, "what is truly devastating is that more than half of these children were healthy — they had no pre-existing conditions," she added. "The flu vaccine is not perfect, we know that…but it will reduce severity and duration of disease and will help save children’s lives."

Doing What We Can, With the Tools That We Have

Asked what clinicians could do to help increase flu vaccine uptake in their communities, Schaffner told BreakingMED that "the single greatest determinant of the acceptance of the vaccine is the nature of the provider’s recommendation, which — and here’s the point — should not be diffident. It’s not sufficient for the provider to say to the patient… as they’re finishing the visit, ’Tom, it’s that season of the year, you ought to think about getting the flu vaccine — we have it available right here in the clinic.’ This doctor thinks that’s a recommendation — that’s not a recommendation. That’s not the way you say to a patient, ’hey Tom, you’ve got pretty bad diabetes here, you ought to think about getting a treatment.’ We don’t say that. We need to be more insistent, ’Tom, it’s that time of the year — as you leave, you will receive your influenza vaccine.’ That’s the way to get people vaccinated. Make it definitive, make it insistent."

"Is the flu vaccine perfect?" Schaffner asked at the conference. "Of course not, we know that. Flu vaccine effectiveness can vary from season to season among different age and risk groups. But it’s important, very important, that people understand that flu vaccines help prevent tens of thousands of hospitalizations each year, and other serious complications such as heart attack and stroke. Even if you do get flu, despite getting vaccinated, please, hear this — you are likely to benefit from having a less severe and shorter illness, and you are far less likely to get pneumonia; you’re less likely to be hospitalized; and you’re less likely to die. Hello? What’s wrong with that?"

"We cannot emphasize any more strongly the importance of what we’re saying today about the benefits of influenza vaccine in general, even if we were not in the middle of the Covid challenge," Fauci said in closing out the conference. Influenza vaccinations are important to prevent infection and to modify infection when you get it. The things that we are talking about now, it is a serious disease, it is not trivial.

"Let’s do what we can, with the tools that we have — and we have a good tool," Fauci added.

*New* Article from physician e-news: Studies Explore TAVR in the Time of Covid-19 10/1/2020 – Salynn Boyles, Contributing Writer, BreakingMED™
Reviewed By: Kevin Rodowicz, DO, Assistant Professor, St. Luke’s University/Temple University

Among patients with severe symptomatic aortic stenosis, delays in performing transcatheter aortic valve replacement (TAVR) early in the Covid-19 pandemic were associated with cardiac events and worse outcomes.

Researchers from Mount Sinai Hospital in New York City reported on 77 cases involving patients with severe aortic stenosis evaluated for TAVR at the institution immediately before the Covid-19 outbreak in the city, including 55 (71.4%) scheduled for TAVR who had their procedures deferred due to Covid-19 and 22 who had their diagnostic testing or appointments cancelled.

On March 22, New York State officials issued an executive order leading to the cancellation of elective procedures. During the following month, 10% of the evaluated patients experienced a cardiac event. Six of the patients required urgent aortic valve replacements, and 2 died due to cardiac causes.

Compared to patients who did not experience cardiac events within the month following the order, those who did had significantly lower left ventricular ejection fraction (mean [SD}, 45% [16%] vs. 56% [14%] (difference, 11%; 95% CI, 0.3%-21%; P=0.04), along with a higher incidence of obstructive coronary disease and New York Heart Association class III and class IV symptoms.

The study is one of two research letters published online Sept. 30 in JAMA Network Open, examining aortic valve replacement triage in the time of Covid-19.

"Patients with advanced symptoms, lower left ventricular ejection fraction, obstructive coronary artery disease, and cerebrovascular accident history represent a high-risk population with aortic stenosis, and the heart team should consider these factors for earlier access to TAVR during the Covid-19 pandemic," wrote Mount Sinai researcher Richard Ro, MD, and colleagues.

In the second analysis, researchers in Switzerland evaluated selection criteria similar to those published in a position statement by the American College of Cardiology and Society for Cardiovascular Angiography & Interventions (ACC/SCAI) to identify candidates for expedited aortic valve replacement during Covid-19 outbreaks.

Between March 20 and April 26, a total of 71 patients with symptomatic severe aortic stenosis were prospectively enrolled in the study, with 25 (35.2%) allocated to expedited aortic valve replacement and 46 (64.8%) allocated to the deferred valve replacement group.

"Patients with critical aortic stenosis defined by an aortic valve area of 0.6 cm2 or less, a trans valvular mean gradient of at least 60 mmHg, cardiac decompensation during the previous 3 months, or exercise intolerance with clinical symptoms on minimal exertion were allocated to expedited aortic valve replacement group," wrote researcher Christoph Ryffel, MD, and researchers from Bern University Hospital, Bern, Switzerland.

Patients with an aortic valve area of 1.0 cm2 or less and greater than 0.6 cm2 and stable symptoms were allocated to deferred aortic valve replacement.

The primary study endpoint was a composite of all-cause mortality, disabling and non-disabling stroke, and unplanned hospitalization for valve-related symptoms or worsening heart failure by intention to treat.

During the study period between mid-March and late-April, all patients allocated to expedited valve replacement underwent TAVR within 10 days of referral, compared to none of the patients in the delayed group.

Among the main findings:

  • Hospitalizations for valve related symptoms or worsening heart failure were more common in patients allocated to deferred aortic valve replacement (AVR) compared with expedited ARV (19.6%vs 0%, P=0.02).
  • Patients in the deferred AVR group who required hospitalization for valve-related symptoms or worsening heart failure more commonly had multivalvular disease (44.4%vs 8.6%, P=0.02).
  • Seven patients (15.2%) hospitalized for valve-related symptoms or worsening heart failure crossed over to expedited transcatheter AVR (n = 4) or surgical AVR (n = 3) within a mean (SD) of 17 (11) days after interdisciplinary allocation of the treatment strategy.
  • One patient allocated to expedited transcatheter AVR experienced a periprocedural nondisabling stroke and none of the patients died.

Compared to patients with no event, patients who experienced a primary outcome–relevant event had a similar delay between confirmation of diagnosis and referral for AVR (mean [SD] delay, 27 [34] days vs 20 [33] days, P=0.58) and comparable rates of New York Heart Association functional class of 3 or more (indicating marked symptoms during daily activity) at baseline (60% vs 41%, P=0.31).

In an accompanying editorial, Massachusetts General Hospital chief of cardiac surgery Thoralf M. Sundt, MD, noted that even though 1 in 5 deferred patients in the study by Ryffel and colleagues reached the composite endpoint, the triage strategy appears to have merit.

"I cannot tell if the authors considered this to be evidence of success or failure, but perhaps apart from adding patients with combined valve disease to the expedited list, it looks to me like success," Sundt wrote.

"Most events were hospitalizations, and the only stroke was in a patient who underwent transcatheter AVR. There were no deaths, which highlights the difficulty of composite endpoints that include occurrences with such widely disparate implications as hospitalization and death."

Sundt noted that together the 2 studies "provide useful guidance," and he added that while the question was not addressed in the studies "it certainly makes sense that, all things being equal, from the patient’s standpoint transcatheter AVR is preferable to surgical AVR, given shorter hospitalization and consequent exposure of patients to Covid-19 in hospital and rehabilitation centers."

"This is true from the standpoint of the health care system as well, undoubtedly conserving intensive care unit and hospital beds relative to surgical AVR. Indeed, the same can be said of proceeding with appropriately expedited procedures even if a second wave of Covid-19 hits," he wrote.

Ro R, et al "Characteristics and outcomes of patients deferred for transcatheter aortic valve replacement because of Covid-19" JAMA Network Open 2020; DOI: 10.1001/jamanetworkopen.2020.19801.

Ryffel C, et al "Mortality, stroke and hospitalization associated withdeferred vs. expedited aortic valve replacement in patients referred for symptomatic severe aortic stenosis during the Covid-19 pandemic" JAMA Network Open 2020; DOI: 10.1001/jamanetwork open.2020.20402.

Sundt TM "Managing aortic stenosisin the age of Covid-19: preparing for the second wave" JAMA Network Open 2020; DOI: 10.1001/jamanetworkopen.2020.20368.

*New* Article from physician e-news: Covid-19 and Alzheimer’s Disease Psychosis: A Role for Pimavanserin? 10/1/2020 – Candace Hoffmann, Managing Editor, BreakingMED™
Reviewed By: Vandana G. Abramson, MD, Associate Professor of Medicine, Vanderbilt University Medical Center

Pimavanserin showed efficacy for patients with Alzheimer’s disease psychosis (ADP) in improving symptoms of psychosis, as well as agitation and aggression, in a 12-week randomized, double-blind, placebo-controlled trial. This finding may be of particular importance in the era of Covid-19, as a recent study found that delirium may be one of the presenting symptoms of the virus in elderly patients with dementia.

"Improvement of psychosis was correlated with the improvement of agitation and aggression at the study’s primary endpoint, in both the overall study population and those with severe agitation and aggression at baseline, supporting the relationship between these two types of symptoms in patients with AD," Clive G. Ballard, of the University of Exeter Medical Schohol, U.K., and colleagues wrote about their pimavanserin study in the International Journal of Geriatric Psychiatry. "This correlation is consistent with the observation that patients with severe psychosis symptoms at baseline (NPI-NH psychosis score ≥ 12) in this study had higher agitation and aggression scores than the overall population and with several studies that have reported significant correlations between psychosis and agitation and aggression in patients with dementia. Collectively, results described here suggest that the improvement in hallucinations and delusions after pimavanserin treatment are related to improvements observed in agitation and aggression."

The need for a treatment for ADP may be even more acute in age of Covid-19, given findings from a study by a team of Italian researchers.

Tino Emanuele Poloni, MD, of the Department of Neurology and Neuropatholgy, Golgi-Cenci Foundation, Milan, and colleagues suggested that delirium is possibly a prodromal phase of Covid-19, especially in patients with dementia who also present with lymphopenia. Their small, single center, retrospective chart review of 59 nursing home residents with dementia found that more than 96 % of these residents tested positive for Covid-19. All of them had comorbidities, with 18 of the 57 residents with Covid-19 having three or more concomitant diseases.

"Delirium-Onset Covid-19 (DOC) was observed in 21/57 (36 8%) subjects who were chiefly older (mean age: 85 -84 y/o) and with multiple comorbidities," Poloni and colleagues wrote. "Eleven/21 DOC patients (52 .4%) had hypoactive delirium, while hyperactive delirium occurred in 10/21 (47. 6%). Lymphopenia was present in almost all subjects (median: 1 .3 X 109/L). Overall mortality rate was 24.6% (14/57) and dementia severity per se had no impact on short-term mortality due to Covid-19. DOC was strongly associated with higher mortality (P<0.001). Also, DOC and male gender were independently associated with increased risk of mortality (OR: 17 0, 95% CI: 2 .8 -102.7, P= 0.002 and 13 6, 95% CI: 2 3 79 2, P = 0.001 respectively)."

Great Need, No Treatment

Currently, there is no approved treatment for ADP, but pimavanserin is FDA-approved for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis (PDP). However, a 6-week, randomized, placebo-controlled trial showed that 51% of patients treated with pimavanserin had a 50% or more improvement in psychotic symptoms (hallucinations and delusions) over baseline, based on the Neuropsychiatric Inventory-Nursing Home Version-Psychosis Score (NPI-NH-PS). The current trial by Ballard and colleagues is a post-hoc analysis of this trial to determine if pimavanserin was also effective in reducing the severity and frequency of agitation and aggression in this patient population.

While anxiolytics or typical and atypical antipsychotic drugs have been prescribed for hallucinations and delusions in ADP, there are "considerable adverse effects," the study authors pointed out.

Ballard and colleagues conducted a post-hoc analysis of the 12-week phase II ACP-103-019 (NCT02035553) trial and evaluated the efficacy of pimavanserin (34 mg) versus placebo for the reduction of psychotic symptoms, which were evaluated as change from baseline of the NPI-NH-PS score at 6 weeks. "At baseline and after 2, 4, 6, 9, and 12 weeks of pimavanserin treatment or placebo, the NPI-NH and the Cohen-Mansfield Agitation Inventory-Short Form (CMAI-SF) were administered," the study authors explained.

Responsiveness and non-responsiveness to pimavanserin for psychotic treatments, particularly its effect on agitation and aggression symptoms, were measured. Responders were defined as those who had a ≥50% improvement from baseline on NPI-NH-PS at week six; those who did not were dubbed non-responders. Additionally, the subgroup of patients treated with the study drug who had more severe agitation and aggression at baseline were also categorized into either responders or non-responders according to the NPI-NH subscale score for agitation/aggression higher than ≥6, which is considered the midpoint.

The study population included nursing home patients with Alzheimer’s disease 50 years or older who "exhibited psychotic symptoms severe enough to warrant treatment with an NPI-NH score of ≥4 in either the delusions or hallucinations domain or a combined score of ≥6 for both measures (delusions + hallucinations)," the study authors wrote. There were 181 patients who met the inclusion criteria — 90 were randomized to the pimavanserin arm and 91 to placebo. The patient’s overall mean age was about 86, and most were female.

"At baseline, patients had an overall mean (standard deviation [SD]) score on the NPI-NH domain C of 4.7 (3.9) and an overall mean (SD) score on the CMAI-SF of 28.6 (8.8). More severe baseline agitation/ aggression symptoms, defined by a score of ≥6 on the NPI-NH domain C subscale, were observed in 43 of 87 (49.4%) pimavanserin-treated patients and 42 of 91 (46.2%) placebo-treated patients," the study authors wrote.

Among the findings:

  • "Pimavanserin-treated patients with ≥50% response in psychotic symptoms (n = 44) showed a greater improvement in agitation and aggression symptoms on the NPI-NH domain C (week six, least squares mean [LSM] difference = −3.64, t = −4.69, P < .0001) and the CMAI-SF (week six, LSM difference = −3.71, t = −2.01, = .0483) than non-responders (n = 32).
  • Differences between psychosis responders and nonresponders were also observed in patients with more severe agitation and aggression at baseline on the NPI-NH domain C (responders, n = 26; non-responders, n = 13; week six, LSM difference = −3.03, t = −2.44, P = .019).

Pimavanserin is under review with the FDA for the treatment of hallucinations and delusions associated with ADP, with a decision pending for April 2021.

Limitations of the study include its post-hoc design and small sample size of pimavanserin-treated patients in the subgroups.

And Then Came Covid-19

In a commentary on Poloni et al’s study, Huali Wang, MD, PhD, from the Dementia Care and Research Center, Beijing, China, noted that "40% - 60% of people with dementia in residential care facilities experience behavioral and psychological symptoms such as agitation, psychosis, or apathy." Wang also observed that previous studies have found neurological changes in patients who contract the SARS-CoV-2 virus.

"Neuropsychiatric changes may characterize either acute or long-term brain dysfunction. The inflammatory process in the central nervous system (CNS), prodromal hypoxia, acute pain, impaired attention, and cognitive-communication deficits due to coronavirus infection may contribute to delirium. Therefore, it was not surprising that Poloni et al found a high prevalence of delirium among people with dementia and Covid-19," Wang wrote.

The significance of this finding, Wang noted, is that if delirium is a prodromal phase of Covid-19, early recognition and testing of dementia patients could help quell the spread of the infection, especially in nursing home settings. However, Wang and Poloni both pointed out that DOC was not seen in house-call service patients and was rarely seen in patients presenting to the emergency room, with the former possibly being because caregivers were not well-versed in recognizing delirium.

Ballard C, et al "Evaluation of the efficacy of pimavanserin in the treatment of agitation and aggression in patients with Alzheimer’s disease psychosis: A post hoc analysis" Int J Geriatr Psychiatry 2020; DOI:10.1002/gps.5381.

Wang H "Delirium: A suggestive sign of Covid-19 in dementia" EClinicalMedicine 2020; DOI: 10.1016/j.eclinm.2020.100524.

Poloni TE, et al "Prevalence and prognostic value of delirium as the initial presentation of Covid-19 in the elderly with dementia: An Italian retrospective study" EClinicalMedicine 2020; DOI: 10.1016/j.eclinm.2020.100490.

*Reminder* Process Change Alert

COVID-19 PCA 023-092820 – N95 Mask ED 3-Shift Usage All was issued on Wed., Sept. 28.

*Reminder* New Testing Approach

As of Thursday, September 24, all patients who become a COVID PUI after admission to a Med/Surg or ICU bed, all inpatients being COVID tested for discharge, and all inpatients who are tested for COVID for a procedure will have their COVID test done in the hospital lab.

*Reminder* CDC Directive for Optimizing the Supply of N95 Masks

The CDC’s Strategies for Optimizing the Supply of N95 masks were written to follow a continuum using the surge capacity approach in the order of conventional (everyday practice), contingency (expected shortages), and crisis (known shortages) capacities. The CDC developed contingency and crisis strategies to help healthcare facilities conserve their supplies in the face of shortages. CHI Memorial has utilized contingency approach for the usage of N95 masks, in that a mask is to be worn three times and then reprocessed or sterilized.  After evaluation of our current community spread, CHI Memorial will move to a conventional approach to N95 mask usage beginning Monday, September 28, 2020.  That means, N95 masks are to be worn one time and then sent for reprocessing.  This approach will be followed until such time as community spread increases or supplies become constrained.  Please follow current instructions for reprocessing after one use.  

*Reminder* Need Hours? Labor Pool Has Openings

There are empty slots available on all campuses. If you can cover a shift at Hixson or Glenwood, please call 495-2294 and for Georgia call 706-858-2761.

The secret of happiness is to live moment by moment and to thank God for all that He, in His goodness, sends to us day after day. – St. Gianna Molla

Current COVID-19 Status:

  • Johns Hopkins Global Coronavirus Tracker: 34,374,469 confirmed; 23,903,631 recovered; 1,024,426 deaths. In the United States, 104,845,628 have been tested; 7,288,166 are confirmed; 2,860,650 have recovered. The United States has a population of 328.2 million people. (10/2/20, 12 p.m.) 
  • 197,432 confirmed cases in Tennessee; 180,781 recovered; 2,501 deaths. Tennessee Department of Health (TDH). 10/1/20  
    • 9,878 confirmed cases in Hamilton County, 9,171 recovered, 97 deaths; 866 cases/842 recovered/4 deaths in Bledsoe County; 2,998 cases/2,835 recovered/17 deaths in Bradley County; 343 cases/237 recovered/6 deaths in Grundy County; 560 cases/496 recovered/8 deaths Marion County; 1,179 cases/1,033 recovered/26 deaths in McMinn County; 232 confirmed/216 recovered/3 deaths in Meigs County; 870 cases/758 recovered/15 deaths in Rhea County; 249 cases/219 recovered/3 deaths in Sequatchie County
  • 319,334 confirmed cases in Georgia; 7,063 deaths. 10/1/20 Georgia Department of Public Health (DPH)
    • 1,212 cases in Catoosa County, 18 deaths; 1,591 in Walker, 38 deaths; 286 cases, 5 deaths in Dade; 4,651 cases, 61 deaths in Whitfield County; 1,880 cases, 37 deaths in Gordon County.
  • 7,213,419 confirmed cases in the U.S.; 206,402 deaths; 55 jurisdictions (50 states, District of Columbia, Puerto Rico, Guam, Northern Marianas, and US Virgin Islands). CDC 10/1/20

CHI Memorial COVID-19 Response 

Visit the resource bank on Mnet for all current COVID-19 information.

 

Key Actions and Updates 

*New* End of Life Visitation

Patients at the end of life may have two visitors at a time, and visitors may rotate between designated visitation times – 9:30 – 11:30 a.m. & 3 – 5 p.m., i.e. Bob and Sue may visit from 9:30 – 11:30 a.m., Joe and Dee may visit from 3 – 5 p.m. 

*New* Process Change Alert

COVID-19 PCA 023-092820 – N95 Mask ED 3-Shift Usage All was issued on Wed., Sept. 28.

*New* PPE Supply Guide Alert

CHI Memorial has tracked its supply of PPE in real time, since the beginning of the COVID-19 pandemic, and measures par levels against documented usage.  This Guide is a confidential internal document and is not to be emailed or shared outside our organization.  Our intent is to make certain that all employees are informed on the exact product that will be stocked by type. Click here to review the Sept. 30 PPE Supply Guide Alert.

*New* CommonSpirit Health COVID-19 Bulletin

Important information about the ministry’s response to COVID-19 is published in CommonSpirit Health’s Daily Bulletin. Click here to review the Sept. 29 bulletin. Other editions can be found on the Mnet.

*New* Article from physician e-news: Parkinson’s Disease: Covid-19 Exacerbates Symptoms, Disrupts Care 9/30/2020 – John McKenna, Associate Editor, BreakingMED™

Reviewed By: Vandana G. Abramson, MD, Associate Professor of Medicine, Vanderbilt University Medical Center

Results from a survey of adults both with and without Parkinson’s disease (PD) suggested that the ongoing Covid-19 pandemic has a dramatic impact on motor and non-motor symptoms of PD and led to significant disruptions in care.

"Out of about 5,000 people with PD, about 1% had a definite or probable Covid-19 diagnosis, and 75% of those infected experienced new or worsening PD-related symptoms," wrote Caroline M. Tanner, MD, PhD, of the Department of Neurology in the Weill Institute for the Neurosciences, University of California San Francisco, and colleagues reported in the Journal of Parkinson’s Disease. "For people with PD without Covid-19, disruptions were frequent in PD-related medical care (64%), essential daily activities (35%), exercise (21%), and social activity (57%), and contributed to worsening of motor and non-motor symptoms especially in specific at-risk groups. Compensatory activities such as telemedicine and online exercise and social programs are important, though these are not available to everyone. As the pandemic and social distancing guidelines will likely last for some time, targeted strategies should be developed to provide support to patients with all levels of resources."

For their study, Tanner and colleagues invited participants from the online Fox Insight study, with or without PD, to complete a survey from April 23 through May 23, 2020. Patients with missing diagnostic or demographic data and patients who reported a PD diagnosis before age 25 were excluded. Of the 9,762 patients in Fox Insight, 7,209 responded (~74% response rate), 5,429 of whom had PD and 1,452 of whom did not.

The researchers noted that respondents with PD were older, more often male, had a higher prevalence of heart disease, had a lower prevalence of immunocompromising conditions and lung disease, and had lower household income than those without PD.

"Covid-19 diagnoses were reported by 51 people with PD (22 definite, 29 probable) and 26 people without PD (7 definite, 19 probable)," they reported. "Positive tests were reported in 17 people with PD and 6 without PD. One person with PD reported a positive Covid-19 test but was asymptomatic and was not included in analyses of Covid-19-associated disease features."

Covid-19 and Parkinson’s Disease Symptoms

Tanner and colleagues found that, among the respondents who reported Covid-19 infection, "people with PD reported worsening of many PD-related symptoms. New motor symptoms were reported by 18%, and 55% reported worsening of at least one existing motor symptom. New and worsening non-motor symptoms were reported for all domains: mood (20% new, 51% worsening), cognition (7.8% new, 41% worsening), sleep (12% new, 59% worsening), and autonomic (7.8% new, 29% worsening)."

Patients with PD who develop infectious illnesses often report worsening PD symptoms, the study authors noted, "possibly due to systemic inflammation, altered dopaminergic signaling, or changes in medication absorption or pharmacokinetics. Worsening of symptoms due to a direct infection of the [central nervous system] CNS by SARS-CoV-2 is less likely. Although Covid-19 has been associated with changes on neuroimaging and SARS-CoV-2 RNA has been detected in cerebrospinal fluid, a recent autopsy series of patients that died with Covid-19—all of whom experienced altered mental status—did not find immunohistochemical evidence of encephalitis or viral invasion into brain tissue. Exacerbation of PD symptoms during Covid-19 may in part be due to the inflammatory reaction characteristic of the disease. The consistent reporting of symptom exacerbation in people with PD due to Covid-19 emphasizes the need to consider Covid-19 as a possible explanation for suddenly worsening PD-related symptoms."

Tanner and colleagues also found that survey respondents with Covid-19, both with and without PD, reported new onset hyposmia, a reduced ability to smell and detect odors—and, PD patients who already had hyposmia reported worsening of this symptom while infected with Covid-19. This symptom was reported at a similar rate to subjective reports in previous studies, they noted.

Disruptions to PD-Related Care

While the vast majority of respondents with PD did not develop Covid-19, 62% reported alterations to healthcare as a result of the pandemic, including cancelled appointments, reduced in-home care, or trouble filling prescriptions. "People with PD not diagnosed with Covid-19 reported disrupted medical care (64%), exercise (21%), and social activities (57%), and worsened motor (43%) and non-motor (52%) symptoms," Tanner and colleagues reported.

Notably, disruption in medical care was more common among those with longer PD duration (41% PD duration >9 years vs 32% for PD duration 0–3 years, adjusted odds ratio [aOR] = 1.47, 95% CI 1.26–1.73, P< 0.001), the study authors pointed out. Meanwhile, race and low income were both independently associated with difficulty obtaining PD medications (non-White race 13% vs 7.3%, aOR 1.98 95% CI 1.05–3.45, P= 0.023, and lower income 10% vs 7.2%, aOR 1.36, 95% CI 1.07–1.72, P= 0.01), with Latinx patients reporting the largest disruption (14% vs 7.5%, 1.61, 95% CI 0.93–2.63, P= 0.07).

"Telemedicine appointments were reported by 39% of people with PD," the study authors added, "but those with lower household income were less likely to attend healthcare appointments through telemedicine (40% vs 35%, aOR 0.79, 95% CI 0.69, 0.90, P<0.001)."

Thirty-five percent of respondents with PD reported at least one essential daily activity getting disrupted during the pandemic, they wrote. These disruptions were more commonly reported among patients who lived alone compared to others with PD, including getting food (12% versus 8.7%) and getting home care/housekeeping (15% versus 9%). In addition, 21% and 57% of respondents with PD reported cancelled exercise or social activities, respectively. While many respondents found alternative ways to pursue these activities, such as online classes, PD patients with lower income were less likely to report alternative means of exercising (32% versus 44%) or social activities (49% versus 58%), and older PD patients were less likely to use alternative ways to exercise (39% versus 44%).

The pandemic also hampered patients’ participation in ongoing research — of the 16% of PD patients without Covid-19 who reported participating in research, 40% had to cancel and 35% had to postpone in-person research visits, and 25% were unable to participate in research visits through alternative methods.

These disruptions in care apparently had a substantial impact on patient outcomes, Tanner and colleagues wrote, with patients who experienced interruptions in care more likely to report worsening PD symptoms in all domains (motor symptoms: 56% versus 36%; cognitive problems: 24% versus 4%; mood symptoms: 42% versus 30%; autonomic symptoms: 27% versus 17%; and sleep problems: 42% versus 31% [for all <0.001]). "New onset motor symptoms in particular were more likely in those that had disruption of medical care (8.2% versus 5.1% aOR 1.63, 95% CI 1.31-2.04, P<0.001)," they noted.

"Respondents who experienced interruptions to exercise, social activities or were asked to self-isolate were also more likely to report worsening of PD symptoms," Tanner and colleagues added.

The study authors noted that the fact that 35% of people with lower socioeconomic status were able to use telemedicine resources to continue care is encouraging and suggests that this service can be further expanded; however, they also noted that it is vital to minimize the adverse effects of treatment interruptions while continuing to maintain safety precautions. Their study also suggests that patients with longer PD duration and patients living alone need more specific attention, and that existing socioeconomic and racial barriers to healthcare have been further exacerbated by the pandemic, they added.

Parkinsonism: The Third Wave of the Covid-19 Pandemic?

Tanner and colleagues also noted that their study raises important questions for future analyses, including the potential for long-term neurological repercussions for patients who develop SARS-CoV-2 infection.

"Hyposmia predicts PD-associated clinical and pathological changes," they wrote. "This association, among other neurologic manifestations in people with Covid-19, has prompted worries about the possibility of SARS-CoV-2 infection triggering long-term neurodegeneration, as was observed following the 1917-1918 [Spanish flu] pandemic. This survey will provide useful baseline information for follow-up of respondents with Covid-19, to see if parkinsonism or other neurodegenerative diseases develop in those without PD, or if a different clinical course occurs in those with PD."

This sentiment echoed concerns raised in a review of reported neurological symptoms associated with Covid-19 infection, published this month in the Journal of Parkinson’s Disease, in which Kevin J. Barnham, PhD, of the Florey Institute of Neuroscience and Mental Health, the University of Melbourne, and the Melbourne Dementia Research Centre in Parkville, Australia, and colleagues warned that parkinsonism may prove to be the "third wave" of the Covid-19 pandemic.

"There may be a myriad of potential long-term neurological and neuropsychiatric complications secondary to SARS-CoV-2 infection including a potential link to worsening parkinsonism in patients with PD and possibly even delayed neurological effects including parkinsonism," they wrote. "It remains to be seen whether Covid-19 viral infections will be later linked to parkinsonism as is the case in other viruses. Also, unlike many neurological conditions, such as neuropathy, there are emerging tools available to identify parkinsonism early in the disease process. As such, this review serves as a ’call to arms’ for the neurology community in preparation of a potential wave of parkinsonism to come."

Barnham and colleagues pointed to several systematic reviews and case reports that reported neurological symptoms in patients with Covid-19, including acute cerebrovascular disease, dizziness, headache, hypogeusia, impaired consciousness, Guillain-Barre syndrome, neuralgia, epilepsy, ataxia, encephalitis, and hyposmia. However, they also acknowledged that "there is insufficient data at this stage to quantify the increased risk of developing parkinsonism associated with Covid-19."

Nonetheless, they encouraged researchers to undertake population-based studies of the neurological symptoms of SARS-CoV-2 infection, and they called for "substantial investment in the early identification, diagnosis, and treatment of PD and parkinsonism to help arm clinicians with the best tools available to handle a potential influx of parkinsonism over the next half-century."

For their own study, Tanner and colleagues noted several limitations, including a modest response rate, reliance on self-reporting, an inability to capture Covid-19 cases that resulted in death, and underrepresentation among certain populations. However, they argued that this survey provides a useful opportunity to evaluate the long-term effects of Covid-19 on PD progression and the social and public health impacts of the pandemic on this patient population.

"The Covid-19 pandemic will likely have long-term repercussions; intervention to mitigate those effects in our patients should begin as soon as possible," they added.

Tanner CM, et al "The effect of the Covid-19 pandemic on people with Parkinson’s disease" Journal of Parkinson’s Disease 2020; DOI: 10.3233/JPD-202249.

Barnham KJ, et al "Parkinsonism as a third wave of the Covid-19 pandemic?" Journal of Parkinson’s Disease 2020; DOI: 10.3233/JPD-202211.

*New* Article from physician e-news: Covid-19: AMA Pushes Flu Vax as Pandemic Rages On 9/30/2020 – John McKenna, Associate Editor, BreakingMED

The American Medical Association (AMA) released a statement to strongly suggest that everyone in the U.S. older than six months get their flu vaccine to help blunt the impact of the simultaneous 2020-21 flu season and ongoing Covid-19 pandemic.

"Just as wearing a mask helps prevent the spread of SARS-CoV-2, getting the flu vaccine helps prevent individuals from becoming ill, as well as prevents further spread to others. Vaccines bolster the health of communities as some people cannot be vaccinated—including very young children, cancer patients and those who are immunosuppressed," the AMA argued. "When immunization rates are high, people in these categories are protected because they’re less likely to be exposed to the disease."

The AMA called flu vaccination "part of a comprehensive public health strategy to reduce the burden of flu in the population and to preserve scarce health care resources as we continue to respond to the pandemic." However, the organization also acknowledged that the pandemic could potentially impact when, where, and how people get their flu vaccine.

"The Centers for Disease Control and Prevention (CDC) has developed guidance to help physicians administer vaccinations during the pandemic to ensure patient safety," the AMA explained. "For patients going to their physician, they will find offices reorganized to protect patients from Covid-19. The pandemic has prompted physicians to modify how they operate safely while continuing to provide patients with essential services. There may be fewer appointments available as offices are disinfecting between patients and making sure patients are not intermingling."

The AMA also pointed out that people who are used to receiving their flu shot at work might not have that option, as many organizations are still working from home. Patients in this group might need to resort to drop-in clinics or discuss with their physician the best way to receive their vaccine. The CDC made an online tool to assist patients looking for somewhere to get vaccinated.

"Flu activity increases in October and most often peaks between December and February—and can last as late as May," the organization added. "While fall is the ideal time to get the flu vaccine, it’s never too late."

"We need to realize that we are all interconnected, said AMA President Susan R. Bailey, MD, in a statement, "and during this pandemic, getting vaccinated is a step to protect our individual and collective health."

*New* Article from physician e-news: Post-Covid Clinics Get Jump-Start From Patients With Lingering Illness 9/30/2020 – Julie Appleby, Kaiser Health News

Clarence Troutman survived a two-month hospital stay with Covid-19, then went home in early June. But he’s far from over the disease, still suffering from limited endurance, shortness of breath and hands that can be stiff and swollen.

"Before Covid, I was a 59-year-old, relatively healthy man," said the broadband technician from Denver. "If I had to say where I’m at now, I’d say about 50% of where I was, but when I first went home, I was at 20%."

He credits much of his progress to the "motivation and education" gleaned from a new program for post-Covid patients at the University of Colorado, one of a small but growing number of clinics aimed at treating and studying those who have had the unpredictable coronavirus.

As the election nears, much attention is focused on daily infection numbers or the climbing death toll, but another measure matters: Patients who survive but continue to wrestle with a range of physical or mental effects, including lung damage, heart or neurological concerns, anxiety and depression.

"We need to think about how we’re going to provide care for patients who may be recovering for years after the virus," said Dr. Sarah Jolley, a pulmonologist with UCHealth University of Colorado Hospital and director of UCHealth’s Post-Covid Clinic, where Troutman is seen.

That need has jump-started post-Covid clinics, which bring together a range of specialists into a one-stop shop.

One of the first and largest such clinics is at Mount Sinai in New York City, but programs have also launched at the University of California-San Francisco, Stanford University Medical Center and the University of Pennsylvania. The Cleveland Clinic plans to open one early next year. And it’s not just academic medical centers: St. John’s Well Child and Family Center, part of a network of community clinics in South Central Los Angeles, said this month it aims to test thousands of its patients who were diagnosed with Covid since March for long-term effects.

The general idea is to bring together medical professionals across a broad spectrum, including physicians who specialize in lung disorders, heart issues and brain and spinal cord problems. Mental health specialists are also involved, along with social workers and pharmacists. Many of the centers also do research studies, aiming to better understand why the virus hits certain patients so hard.

"Some of our patients, even those on a ventilator on death’s door, will come out remarkably unscathed," said Dr. Lekshmi Santhosh, an assistant professor of pulmonary critical care and a leader of the post-Covid program at UC-San Francisco, called the OPTIMAL clinic. "Others, even those who were never hospitalized, have disabling fatigue, ongoing chest pain and shortness of breath, and there’s a whole spectrum in between."

’Staggering’ Medical Need

It’s too early to know how long the persistent medical effects and symptoms will linger, or to make accurate estimates on the percentage of patients affected.

Some early studies are sobering. An Austrian report released this month found that 76 of the first 86 patients studied had evidence of lung damage six weeks after hospital discharge, but that dropped to 48 patients at 12 weeks.

Some researchers and clinics say about 10% of U.S. Covid patients they see may have longer-running effects, said Dr. Zijian Chen, medical director of the Center for Post-Covid Care at Mount Sinai, which has enrolled 400 patients so far.

If that estimate is correct — and Chen emphasized that more research is needed to make sure — it translates to patients entering the medical system in droves, often with multiple issues.

How health systems and insurers respond will be key, he said. More than 6.5 million U.S. residents have tested positive for the disease. If fewer than 10% — say 500,000 — already have long-lasting symptoms, "that number is staggering," Chen said. "How much medical care will be needed for that?"

Though startup costs could be a hurdle, the clinics themselves may eventually draw much-needed revenue to medical centers by attracting patients, many of whom have insurance to cover some or all of the cost of repeated visits.

Chen at Mount Sinai said the specialized centers can help lower health spending by providing more cost-effective, coordinated care that avoids duplicative testing a patient might otherwise undergo.

"We’ve seen patients that when they come in, they’ve already had four MRI or CT scans and a stack of bloodwork," he said.

The program consolidates those earlier results and determines if any additional testing is needed. Sometimes the answer to what’s causing patients’ long-lasting symptoms remains elusive. One problem for patients seeking help outside of dedicated clinics is that when there is no clear cause for their condition, they may be told the symptoms are imagined.

"I believe in the patients," said Chen.

About half the clinic’s patients have received test results showing damage, said Chen, an endocrinologist and internal medicine physician. For those patients, the clinic can develop a treatment plan. But, frustratingly, the other half have inconclusive test results yet exhibit a range of symptoms.

"That makes it more difficult to treat," said Chen.

Experts see parallels to a push in the past decade to establish special clinics to treat patients released from ICU wards, who may have problems related to long-term bed rest or the delirium many experience while hospitalized. Some of the current post-Covid clinics are modeled after the post-ICU clinics or are expanded versions of them.

The ICU Recovery Center at Vanderbilt University Medical Center, for instance, which opened in 2012, is accepting post-Covid patients.

There are about a dozen post-ICU clinics nationally, some of which are also now working with Covid patients, said James Jackson, director of long-term outcomes at the Vanderbilt center. In addition, he’s heard of at least another dozen post-Covid centers in development.

The centers generally do an initial assessment a few weeks after a patient is diagnosed or discharged from the hospital, often by video call. Check-in and repeat visits are scheduled every month or so after that.

"In an ideal world, with these post-Covid clinics, you can identify the patients and get them into rehab," he said. "Even if the primary thing these clinics did was to say to patients, ’This is real, it is not all in your head,’" he added, "that impact would be important."

A Question of Feasibility

Financing is the largest obstacle, program proponents say. Many hospitals lost substantial revenue to canceled elective procedures during stay-at-home periods.

"So, it’s not a great time to be pitching a new activity that requires a startup subsidy," said Glenn Melnick, a professor of health economics at the University of Southern California.

At UCSF, a select group of faculty members staff the post-Covid clinics and some mental health professionals volunteer their time, said Santhosh. Mount Sinai’s Chen said he was able to recruit team members and support staff from the ranks of those whose elective patient caseload had dropped.

Jackson, at Vanderbilt, said unfortunately there’s not been enough research into the cost-and-clinical effectiveness of post-ICU centers.

"In the early days, there may have been questions about how much value does this add," he noted. "Now, the question is not so much is it a good idea, but is it feasible?"

Right now, the post-Covid centers are foremost a research effort, said Len Nichols, an economist and nonresident fellow at the Urban Institute.

"If these guys get good at treating long-term symptoms, that’s good for all of us," said Nichols. "There’s not enough patients to make it a business model yet, but if they become the place to go when you get it, it could become a business model for some of the elite institutions."

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

*New* Article from physician e-news: Covid-19: Kids May Well Be Less Prone to Infection

9/29/2020 – Shalmali Pal, Contributing Writer, BreakingMED™

Reviewed By: Anupama Brixey, MD, Assistant Professor in Cardiothoracic Imaging, Oregon Health and Science University

Children seem to have a lower susceptibility to SARS-CoV-2 infection versus adults, but the exact role kids, including adolescents, play in transmission of this virus is not clear, according to a meta-analysis.

In the review of 32 studies with more than 41,000 young people (ages <10 to 14 years) and nearly 269,000 adults, the pooled odds ratio of being an infected contact in children compared with adults was 0.56 (95% CI 0.37-0.85), with substantial heterogeneity (I2=94.6%), reported Russell M. Viner, PhD, of the UCL Great Ormond Street Institute of Child Health in London, and co-authors.

Also, "most studies were consistent with lower seroprevalence in children compared with adults, although seroprevalence in adolescents appeared similar to adults," they wrote in JAMA Pediatrics.

The authors pointed out that "There is weak evidence that children and adolescents play a lesser role than adults in transmission of SARS-CoV-2 at a population level," and that "This study provides no information on the infectivity of children."

But the study "helps bring us a step closer to understanding [the] dynamics" and "precise role of children in the transmission of SARS-CoV-2," noted Saul N. Faust, MD, PhD, and Alasdair P. S. Munro, MD, both of the National Institute of Health Research Southampton Clinical Research Facility, University Hospital Southampton NHS Foundation Trust in England, in an accompanying editorial. "In spite of everything we have known and understood about respiratory viral infections to date, it does now appear that children overall are relatively less susceptible to becoming infected as well having less severe infection itself."

The concept of less susceptibility has been borne out by other contract-tracing research, such as that out of AustraliaSingapore, and Ireland — all of which showed low or no evidence of secondary transmission from children attending school — as well as data from England post-school reopening, they stated. Other research, including another meta-analysis and a study done in 25 EU countries, also support the theory that children are in a better position than adults to handle Covid-19.

Still, Faust and Munro acknowledged that studies out of France and Israel did not paint such a rosy picture of transmission rates in high school kids. Additionally, research out of China reported that the virus had a higher "pathophysiological impact" in children, while investigators at Massachusetts General Hospital in Boston found that asymptomatic or low-symptom children still carried a higher viral load.

And research has shown ties between Covid-19 and other disorders, such as cardiac endotheliitis, multisystem inflammatory syndrome, asthma, obesity, and neurologic/developmental conditions. Finally, racial and/or ethnic minorities, as well as socioeconomically disadvantaged children, carried the highest burden of infection, according to a study out of the Children’s National Hospital in Washington, DC.

Not surprisingly, Fause and Munro called interpretation of these data complicated, noting that "[one] fundamental question has not yet been answered. So far, the direction of spread has been difficult to elucidate in that it has been impossible to determine the relative proportion of teacher (adult)-to-child spread compared with child-to-child spread."

Also, there is the issue of "crossover of the exposure, as many children have shared the initial infection exposures with supposed secondary contacts. This means the adults and children have actually become infected at the same time, there has likely been some misclassification of index cases, as this is often determined by who becomes symptomatic first," they said.

However, they stressed that the debate over the opening of schools should "avoid further politicization… It is not so simple as to say that children are not affected and cannot transmit, nor to say that schools should be closed or risk near certainty of propagating a second wave of infections. Schools cannot be opened with impunity in the setting of moderate to high community transmission, nor can they be kept closed indefinitely."

Any "national strategy to reopen" should not use children as "a political football," Faust and Munro emphasized.

Viner’s group combed PubMed and medRxiv through July 28, 2020, and ultimately settled on met 18 contact-tracing studies and 14 population screening studies. Half a dozen studies were from Guangdong province in China and two were from the U.S., with others were from countries including South Korea, Israel, Taiwan, the Netherlands, Australia, Brunei, India, and Singapore.

They explained: "We hypothesized that [contact-tracing studies] including only household contacts might provide a clearer indication of the relative susceptibility to infection of children versus adults because all contacts within households might be assumed to receive a similar exposure to infection from index cases" and reported that a trio of "school-based contact-tracing studies found minimal transmission from child or teacher index cases."

But "findings from population screening studies were heterogeneous and were not suitable for meta-analysis," the authors stated. They noted that "Examination of seroprevalence findings in children separate from adolescents showed that most studies were consistent with lower seroprevalence in children compared with adults, although seroprevalence in adolescents appeared similar to adults in all studies."

Viner and co-authors cautioned that the number of children tested was small for the population screening studies, and that the majority of the contact-tracing studies were done once social distancing was in place so interactions outside the home were reduced. In addition, most of the studies were from middle-income and high-income countries.

Finally, "We remain early in the Covid-19 pandemic, and data continue to evolve. It is possible that unknown factors related to age, e.g., transience of infection or waning of immunity, bias findings in ways we do not yet understand," they wrote, adding that they would continue to update the review as new data came out.

Viner RM, et al "Susceptibility to SARS-CoV-2 infection among children and adolescents compared with adults: A systematic review and meta-analysis" JAMA Pediatr 2020; DOI: 10.1001/jamapediatrics.2020.4573.

Faust SN, Munro APS ""It’s time to put children and young people first during the global Covid-19 pandemic" JAMA Pediatr 2020; DOI: 10.1001/jamapediatrics.2020.4582.

*New* Article from physician e-news: Covid-19: Age Not a Factor in Response to mRNA-1273 Vaccine

9/29/2020 – Peggy Peck, Editor-in-Chief, BreakingMED™

Reviewed By: Kevin Rodowicz, DO, Assistant Professor, St. Luke’s University/Temple University

The two-dose mRNA-1273 vaccine for Covid-19 being developed by the National Institutes of Allergy and Infectious Diseases (NIAAD) and Moderna induced an effective antibody response with no apparent safety signal in a preliminary study of 40 older adults, investigators with the trial reported in a study published online by The New England Journal of Medicine.

"Potently immunogenic vaccine designs are particularly relevant for older adults, since severe or fatal cases of Covid-19 occur more often in this population," wrote Evan J. Anderson, MD, of Emory University in Atlanta, and co-investigators. "Although the sample sizes in our study were limited, older participants (including those who were 71 years of age or older) had immunologic responses to the mRNA-1273 vaccine 1 month after the second dose and across multiple assays that were similar to the responses among younger participants."

In July, these researchers reported positive findings from a cohort of younger volunteers (age 18 to 55). However, as pressure builds to identify an effective vaccine as part of the so-called "Operation Warp Speed," the need for findings about vaccine immunogenicity in at risk populations—such as older adults—has taken on added urgency.

This time, Anderson et al reported results from a phase I open-label trial that recruited 40 healthy "older" adults ages 56 to 70 or 71 and older to test two doses of the vaccine: 25 μg and 100 μg. They assigned 10 volunteers to one of four groups so that each age group had 10 volunteers in each of the dose arms. All participants received two doses administered 28 days apart.

The vaccine "encodes a stabilized version of the SARS-CoV-2 full-length spike glycoprotein trimer, S-2P, which has been modified to include two proline substitutions at the top of the central helix in the S2 subunit," the study authors explained. "The mRNA is encapsulated in lipid nanoparticles at a concentration of 0.5 mg per milliliter and diluted with normal saline to achieve the final target vaccine concentrations."

One participant in the low dose arm did not receive the second dose due to an infection of tissue adjacent to a nail. That infection, paronychia, arose 2 days after the initial vaccination. "This participant was treated with trimethoprim–sulfamethoxazole, and 7 days later, a diffuse maculopapular rash developed," the researchers explained. "The rash was considered by investigators to be unrelated to vaccination and was treated with systemic administration of glucocorticoids."

The investigators noted vaccine responses: "Binding IgG antibody geometric mean titers (GMTs) to S-2P and receptor-binding domain increased rapidly after the first vaccination… and after the second vaccination, responses reached the upper quarter of the distribution of responses among controls who had donated convalescent serum… The GMTs of the participants in the 100-μg subgroup far exceeded the responses among participants who had donated convalescent serum: 1,183,066 GMT (95% CI, 379,698-3,686,201) among participants who were between the ages of 56 and 70 years and 3,638,522 GMT (95% CI, 1,316,233 to 10,058,130) among those who were 71 years of age or older."

Anderson and colleagues noted that there is still no established "correlate of protection for SARS-CoV-2," but they are optimistic about their findings, because neutralizing-antibody levels have correlated with protection in other human viruses, and in animal studies they were shown to be protective against SARS-CoV2.

In addition to its small sample size, the trial was limited by time: it does not provide evidence of durability for the vaccine. The authors explained that "at the time of this interim report, the long-term durability of immunogenicity could not be assessed, although the magnitude of antibody, cellular, and memory responses will be followed for 12 months after the second vaccination. Waning neutralizing-antibody titers have been observed in recipients of DNA vaccines against MERS (Middle East respiratory syndrome) and SARS and in patients with SARS-CoV-2 infection."

The authors also noted that the trial looked at age, but comorbidities, such as diabetes, may be better predictors of immunologic response.

Finally, they pointed out that the 100 μg dose was more effective; thus, their study supports continued evaluation to that dose "in a more diverse population."

Anderson EJ, et al "Safety and immunogenicity of SARS-CoV-2 mRNA-1273 vaccine in older adults" N Engl J Med 2020; Published online September 29 DOI: 10.1056/NEJMoa2028436.

*New* Article from physician e-news: Covid-19: Patients with COPD, Asthma Should Continue Taking ICS

9/29/2020  - Salynn Boyles, Contributing Writer, BreakingMED™

Reviewed By: Anupama Brixey, MD, Assistant Professor in Cardiothoracic Imaging, Oregon Health and Science University

Among patients with COPD or asthma, treatment with an inhaled corticosteroid (ICS) showed no demonstrable benefit or harm with regard to Covid-19 mortality in an observational analysis of electronic primary care records involving more than 1 million patients in the United Kingdom.

While the risk of Covid-19-related death was greater in certain COPD and asthma patients treated with ICS, compared to those not treated with an ICS, sensitivity analysis attributed this increase in risk to small health differences among patients who were and were not prescribed inhaled corticosteroids.

The study findings, published recently online in The Lancet, do not support the conclusion that patients with the chronic airway and lung diseases should alter their ICS treatments during the Covid-19 pandemic, wrote researcher Anna Schultze, PhD, of the London School of Hygiene & Tropical Medicine, and colleagues.

"These results do not support any change to the current clinical guidelines for the routine treatment of people with COPD or asthma with ICS during outbreaks of SARS-CoV-2 infection," they wrote.

They added that previous findings offer conflicting results about the impact of ICS use on Covid-19 mortality.

"The orally or intravenously administered steroid dexamethasone has been shown to reduce the risk of death in people with severe Covid-19," they wrote. "Conversely, although ICSs have low systemic absorption, in people with COPD they have been associated with an increased risk of developing pneumonia and other systemic steroid-related adverse effects. ICS use has also been shown to impair type 1 interferon production, potentially increasing the risk of viral infections."

Their own systematic review exploring the role of ICS in SARS-CoV-2 outcomes, as well as other coronaviruses, turned up no relevant studies addressing the question.

"To answer this question, we aimed to explore the association between current ICS use and Covid-19-related death among people with COPD and asthma using the OpenSAFELY platform, which runs across linked primary care electronic health records (EHR) data for approximately 40% of the population of England," they wrote.

The index date (start of follow-up) for both the COPD and asthma cohorts was March 1, 2020, and follow-up lasted until May 6, 2020.

Patients in the COPD cohort were eligible if they were age 35 years or older, had COPD, were a current or former smoker, and were prescribed an ICS or long-acting β agonist plus long-acting muscarinic antagonist (LABA-LAMA) as combination therapy within the 4 months before the index date.

Patients in the asthma cohort included adults (18+ years) diagnosed with asthma within three years of the index date prescribed an ICS or short-acting β agonist (SABA) only within the 4 months before the index date.

Covid-19-related death outcomes were compared between people prescribed an ICS and those prescribed alternative respiratory medications: ICSs versus LABA-LAMA for the COPD cohort, and low-dose or medium-dose and high-dose ICSs versus SABAs only in the asthma cohort.

Cox regression models were used to estimate hazard ratios (HRs) and 95% CIs for the association between exposure categories and the outcome in each population, adjusted for age, sex, and all other prespecified covariates.

The data search identified 148,557 people with COPD and 818,490 with asthma who were given relevant respiratory medications in the 4 months before the index date.

Among the main study findings:

·         COPD patients prescribed ICSs were at increased risk of Covid-19-related death compared with those prescribed LABA–LAMA combinations (adjusted HR 1.39 [95% CI 1.10-1.76]).

·         Compared with asthma patients prescribed SABAs only, asthma patients prescribed high-dose ICS were at an increased risk of death (1.55 [1.10-2.18]), whereas those given a low or medium dose were not (1.14 [0.85-1.54]).

·         Sensitivity analyses showed that the observed apparent harmful association could "be explained by relatively small health differences between people prescribed ICS and those not prescribed ICS that were not recorded in the database (e value lower 95% CI 1.43)," the researchers wrote.

"The totality of the data presented here, including our sensitivity analyses, do not indicate that regular ICS therapy for asthma or COPD either decreases or increases risk of death from Covid-19 and do not provide evidence to support adjustments in ICS therapy among patients with asthma or COPD during outbreaks of SARS-CoV-2," Schultze and colleagues wrote.

Significant study limitations cited by the researchers involved possible confounding by indication "due to unmeasured or imperfectly defined potential confounding variables," a lack of secondary care data, and the inability to explore the relative impact of ICS use on SARS-CoV-2 severe disease and death.

In addition, the study did not address the role of ICS use in treating Covid-19 among patients without asthma or COPD, which is the subject of 2 ongoing clinical trials (NCT04331054, NCT04330586).

In an editorial published with the study, Professors Dave Singh, of the University of Manchester and David M.G. Halpin, of the University of Exeter, UK, wrote that the analysis by Schultze and colleagues "provides some insights, but not conclusive answers, about whether ICS use impacts Covid-19 outcomes."

"Overall, the analysis is confounded and does not provide definite answers that patients and clinicians need, although it hints that ICS use does not provide a strong protective effect," they wrote.

They concluded that while the impact of regular ICS treatment on the risk of death from Covid-19 is still unclear, the harms of stopping the treatment in patients with COPD or asthma who benefit from it are well documented.

"Until more information is available, patients with asthma and COPD who are stable while using ICS must continue on their treatment during the ongoing Covid-19 pandemic," they wrote.


Schultze A, et al "Risk of Covid-19-related death among patients with chronic obstructive pulmonary disease prescribed inhaled corticosteroids: an obervational cohort study using the OpenSAFELY platform" The Lancet 2020; DOI: 10.1016/S2213-2600(20)3045-X.

Singh D, Halpin DMG "Inhaled corticosteroids and Covid-19-related mortality: confounding or clarifying?" The Lancet 2020; DOI: 10.1016/S2213-2600(20)30447-1.

*New* Article from physician e-news: Covid-19 Worsens In-Hospital Cardiac Arrest Outcomes

9/28/2020 - Paul Smyth, MD, Contributing Writer, BreakingMED™

Reviewed By: Anupama Brixey, MD, Assistant Professor in Cardiothoracic Imaging, Oregon Health and Science University

SARS-CoV-2 infection worsened survival rates for patients with cardiac arrest who received cardiopulmonary resuscitation (CPR) while in the hospital, a case series suggested.

Of 54 hospitalized Covid-19 patients who had in-hospital arrest, 0% survived until discharge and 96% had a nonshockable rhythm, reported Corey Mayer, DO, of William Beaumont Hospital in Royal Oak, Michigan, and coauthors, in JAMA Internal Medicine. Median CPR duration was 10 minutes.

Before the Covid-19 pandemic, a review concluded that 20 to 25% of patients with in-hospital cardiac arrest survived until discharge, and 81% had a nonshockable rhythm (asystole or pulseless electrical activity).

"These outcomes warrant further investigation into the risks and benefits of performing prolonged CPR in this subset of patients, especially because the resuscitation process generates aerosols that may place health care personnel at a higher risk of contracting the virus," Mayer and colleagues wrote"Further studies in this area would be beneficial and potentially aid in informing CPR guidelines for this patient population."

Improving outcomes for Covid-19 patients who have in-hospital cardiac arrest "will be challenging, as few of the likely drivers of poor outcomes (e.g., nonshockable rhythms, respiratory etiologies of arrest, and underlying critical illness) are modifiable," noted J. Randall Curtis, MD, MPH, of the University of Washington in Seattle, and coauthors in an accompanying editorial.

"While these early results should not warrant universal do-not-attempt-resuscitation (DNAR) orders for patients with Covid-19, they highlight the importance of conducting goals-of-care discussions early during the course of Covid-19 and revisiting those discussions with changes in clinical status (worsening or improvement)," Curtis and colleagues wrote. "Moreover, the existing data may warrant clinician recommendations for DNAR, particularly in patients with severe respiratory failure who are at high risk of in-hospital cardiac arrest."

Outcomes of in-hospital cardiac arrest requiring CPR are affected by most patients having a critical illness at the time of arrest and a substantial number of patients with nonshockable initial rhythms, which are associated with worse outcomes. Additional factors present with SARS-CoV-2 infection include a presumed respiratory etiology of arrest, lack of effective therapy for the underlying viral infection, delay because of isolation procedures, limited availability of advanced life support resources, and increased risk of viral transmission.

Outcomes after CPR are important in assessing the appropriateness of resuscitative efforts and to guide professional policy, but limited evidence exists for cardiac arrest in hospitalized patients with Covid-19. An early study in Wuhan, China of 136 Covid-19 patients with in-hospital cardiac arrest found about 94% had reported nonshockable rhythms. The primary outcome, return of spontaneous circulation, was achieved in 13.2%, and 30-day survival was 2.9%.

In this study, Mayer and colleagues studied patients admitted to Beaumont Hospital between March 15 and April 3. Of 1,309 patients with a Covid-19 diagnosis, they identified adults who had CPR for cardiac arrest, excluding those with do-not-resuscitate orders or who were receiving comfort care or hospice care.

Of 54 patients in the study, about 39% were female and median age was 61.5. About 67% were Black, 20% were white, and 3.7% were Asian. Hypertension (78%), diabetes, (56%), and hyperlipidemia (50%) were common. Median body mass index was 33.

Overall, 53.7% achieved the primary outcome of return of spontaneous circulation in median time of 4 minutes. By initial rhythm, the cohort showed:

·         Pulseless electrical activity in 81.5%; return of spontaneous circulation in 54.6%.

·         Asystole in 14.8%; return of spontaneous circulation in 62.5%.

·         Pulseless ventricular tachycardia in 3.7%; return of spontaneous circulation in 0%.

Ventricular fibrillation was not seen. "Despite 29 patients (53.7%) achieving return of spontaneous circulation, none survived to discharge," the researchers noted.

"Outcomes in the setting of Covid-19 may not actually differ from pre-Covid-19 outcomes of in-hospital cardiac arrest for patients with nonshockable rhythms, for whom hospital survival is often less than 15%," the editorialists observed.

"Although this study was not designed to examine racial disparities, it is notable that two-thirds of the patients were Black," they continued. "In the context of Covid-19, Black persons and persons of color are more likely to contract Covid-19 or develop serious illness requiring hospitalization; this association is most likely because of disparities. As such, the urgency of eliminating racial disparities in health care has never been clearer."

A shared focus on promoting early goals-of-care discussions should be a priority, they suggested, recommending The Conversation Project and PREPARE For Your Care to give patients and families Covid-specific guidance.

Limitations of the case series include early, limited data about a new infectious disease and small sample size.

Thapa S, et al "Clinical outcomes of in-hospital cardiac arrest in Covid-19" JAMA Internal Medicine 2020; DOI: 10.1001/jamainternmed.2020.4796.

Modes M, et al "Outcomes of cardiopulmonary resuscitation in patients with Covid-19—Limited data, but further reason for action" JAMA Internal Medicine 2020; DOI: 10.1001/jamainternmed.2020.4779.

*New* Article from physician e-news: Covid-19: Risk Calculator Predicts Progression, Death Among Hospitalized Patients

9/25/2020  - Salynn Boyles, Contributing Writer, BreakingMED™

Reviewed By: Kevin Rodowicz, DO, Assistant Professor, St. Luke’s University/Temple University

A prediction model that combines risk factors known to be associated with severe Covid-19 accurately forecasts progression to severe disease and death in patients newly admitted to hospitals with SARS-CoV-2 infection.

The Covid Inpatient Risk Calculator (CIRC), developed by researchers at Johns Hopkins University School of Medicine, incorporates more than 20 demographic and clinical variables available at hospital admission to predict the likelihood of a patient progressing to severe disease or death within 7 days of patient arrival.

Different combinations of risk factors predicted severe disease or death with probabilities ranging from over 90% to as little as 5% in a study evaluating the model’s prognostic value among 832 patients with Covid-19 treated at Johns Hopkins Hospital and four other affiliated hospitals in Maryland and Washington DC between early March and mid-April.

Study findings were published online this week in Annals of Internal Medicine.

Researcher Brian Garibaldi, MD, of Johns Hopkins School of Medicine, told BreakingMED that the health system’s precision medicine and analytics platform made the model possible.

He said more than 3,000 Covid-19 patients have now been treated through the hospital system, and the goal is to use the analytics platform to further model how treatments and other interventions have impacted patient trajectories and outcomes.

"We are continually learning from the data, recognizing that things have changed over time and continue to change," he said, adding that both longitudinal and intervention data are being incorporated into models designed to better inform clinicians and assist patients and their families.

The median age of the 832 patients hospitalized for Covid-19 at the 5 affiliated hospitals between March 4 and April 24 was 64 years (range 1 to 108 years), and roughly half (47%) were female. Blacks made up 40% of the population, 16% were Latino, and 21% were residents of nursing homes.

A total of 131 patients (16%) died during their hospital stay and 694 (83%) were discharged. Sixty-three percent of patients had mild to moderate disease and 20% had severe disease.

Half of the patients who died (66 of 131) were nursing home residents, and 38% of patients admitted with mild to moderate disease progressed to severe disease.

Among the patients that progressed, 60% progressed to severe disease by day 2 in the hospital and 79% progressed by day 4.

"Patients had markedly different probabilities of disease progression on the basis of age, nursing home residence, comorbid conditions, obesity, respiratory symptoms, respiratory rate, fever, absolute lymphocyte count, hypoalbuminemia, troponin level, and C-reactive protein level and the interactions among these factors," the researchers wrote.

Using only factors present on admission, the CIRC model had an area under the curve of 0.85, 0.79, and 0.79, at day 2, 4, and 7, respectively.

Ninety percent of deaths occurred in patients who were age 60 years or older. Hypertension, coronary artery disease, chronic kidney disease, and cancer were all associated with higher mortality, but the prevalence of diabetes and chronic lung disease was similar across the groups.

Of 179 (22%) mechanically ventilated patients, the median time to ventilation was 1.2 days (IQR, 0.1 to 3.1 days) and the median duration of mechanical ventilation was 10.5 days (IQR, 3.9 to 21.2 days) overall, 11.6 days (IQR, 6.7 to 22.9 days) for discharged patients (102 [57%]), and 7.1 days (IQR, 1.3 to 16.6 days) for those who died (70 [39%]). Of the 6 patients (0.7%) placed on extracorporeal membrane oxygen, 3 died and 3 were discharged.

Garabaldi and colleagues noted that age significantly modified associations with sex, multiple comorbid conditions, and detectable troponin level.

Factors associated with progression to severe disease or death independent of age included:

·         BMI (a change in risk by 4 days from 13% to 16% for each 5-point increase).

·         Respiratory symptoms (a change in risk by 4 days from 13% to 30%).

·         CRP level, respiratory rate, albumin level.

·         Temperature greater than 38.0 °C (a change in risk by 4 days from 13% to 23%).

"Different combinations of risk factors predict severe disease or death with probabilities ranging from over 90% to as little as 5% (that is, 18-fold for patients at highest risk compared with those at lowest risk)," the researchers wrote.

One in five patients who died, including almost all patients who died without receiving mechanical ventilation, had DNR/DNI orders at the time of admission.

Obesity was strongly associated with severe disease and death, but race/ethnicity did not predict poor outcomes after adjustment for clinical factors.

The model was most accurate for predicting progression to severe disease or death within the first 2 days after hospital admission, but it performed well for predicting progression through day 7, Garibaldi said.

He said models incorporating longitudinal patient data may prove more useful for predicting patient outcomes beyond this period.

Garibaldi BT, et al "Patient trajectories among persons hospitalized for Covid-19" Ann Intern Med 2020; DOI: 10.7326/M20-3905.

*New* Article from physician e-news: Death Risk High in CLL Patients Infected with Covid-19

9/25/2020  - am Harrison, Contributing Writer, BreakingMED™

Reviewed By: Vandana G. Abramson, MD, Associate Professor of Medicine, Vanderbilt University Medical Center

The risk of death from Covid-19 in patients with chronic lymphocytic leukemia (CLL) is high, whether patients are receiving active therapy at the time of infection, have previously received CLL treatment, or are being treated with a "watch-and-wait" approach, a multicenter, an international descriptive study found.

At a median follow-up of only 16 days (range, 1-43 days), the mortality rate for patients on active CLL-directed therapy at the time of Covid-19 diagnosis was 28%, Anthony Mato, MD, Memorial Sloan Kettering Cancer Center, New York City, and multi-center colleagues reported in Blood. Case fatality rates were similar for patients who had ever received CLL-directed therapy at 32% and for watch-and-wait patients at 37%, they added.

The overall-case fatality rate for the current series of 198 patients was 33%, but it was 37% among patients requiring hospital admission. However, as investigators pointed out, this is likely an under-estimation of the true case fatality rate for those hospitalized with Covid-19, as 49 patients who had been admitted to hospital because of the infection remained as inpatients at the time of analysis, Mato and colleagues noted. For the 129 patients who had been discharged or who had died at the time of the analysis, the case fatality rate was 50%.

"CLL patients have impaired humoral and cellular immune function, [so] we hypothesized that this cohort might be at particular risk of severe Covid-19 with its associated morbidity, including superimposed infections, and mortality," the authors explained. "These data suggest that the subgroup of CLL patients admitted with Covid-19, regardless of disease phase or treatment status, are at high risk of death."

International Centers

CLL patients who were diagnosed with symptomatic Covid-19 from 43 different international centers were included in the analysis and had the following characteristics:

·         The median age at initial diagnosis of CLL was 63 years (range, 35-92 years) while the mean age at the time of Covid-19 diagnosis was 70.5 years (range, 38-98 years).

·         Ninety percent of patients in the analysis required admission to the hospital.

·         The majority of the group (61%) had previously received at least one line of CLL therapy, and 45% were on active CLL therapy when diagnosed with the infection.

·         Approximately three-quarters of those on active therapy at the time of diagnosis were receiving a Bruton tyrosine kinase (BTK) inhibitor.

"Many patients had a significant burden of comorbidities, with a median CIRS (cumulative illness rating score) of 8 (range, 4-32)," the research team observed. Specifically, among patients with CLL included in this study:

·         Approximately half of the group had hypertension.

·         44% had hypogammaglobulinemia.

·         20% had a history of arrhythmia.

·         20% had diabetes.

·         17%% had either asthma or chronic obstructive pulmonary disease.

·         17% had chronic renal disease.

On presentation, 88% of patients had fever, 85% of patients had cough, and more than 70% of patients reported fatigue and dyspnea, while 36% complained of myalgia or arthralgia. Mato and colleagues noted that the rates of hospital admission, ICU admission, and intubation were very similar between patients who had previously received treatment for CLL and the watch-and-wait group.

Of the 178 patients who required hospital admission, 92% required supplemental oxygen, 38% required admission to the intensive care unit (ICU), 27% needed IV vasopressor support, and 11% required dialysis.

As has been seen in other Covid-19 cohorts, death rates for patients who required supplemental oxygen, intubation, and mechanical ventilation were 39%, 43%, and 55%, respectively, and all were higher than they were for those who did not require the same level of intensive care.

The authors had anticipated that BTK inhibitor use might favorably affect overall survival (OS). However, in this particular cohort, BTK inhibitors did not appear to affect survival outcomes, although the majority of those who were receiving BTK inhibitor therapy at the time of diagnosis had their drug withheld.

The authors also found that, within their CLL-specific inpatient group, individual risk factors associated with a poor prognosis included advanced age of 75 years and older, a CIRS score in excess of 6, chronic renal disease, and asthma.

"These data show that known risk factors from non-cancer population-based data also modulate outcomes in CLL patients," Mato and colleagues observed.

Indeed, the mortality rates observed in this particular cohort of CLL patients appeared to be at least similar to those from a large series of "all comer" symptomatic Covid-19 patients requiring hospitalization, as they pointed out.

The authors acknowledged that the follow-up of this particular patient group is short and will require a longer interval to better appreciate the impact of Covid-19 infection on patients with CLL.

Management of the infection was also variable across the different international settings.

Given that there was (and still is) no established standard of care for Covid-19 management, investigators could not comment on the optimal management strategy for patients infected with Covid-19.

Commenting on the study, Emili Montserrat, MD, University of Barcelona, Spain, underscored the fact that the case fatality rate of patients requiring hospital admission (37%) in the current study was "remarkably similar" to the case fatality rate of 36.4% reported among a cohort of symptomatic CLL patients in Europe.

"Not surprisingly," Montserrat noted, the death rate was higher in patients with severe Covid-19 (over 60%) than in those with milder course of infection (38.5%) in the same CLL study group. Interestingly, the death rate in patients with any type of cancer was much lower (5.6%) in a large series of Covid-19-infected patients from China.

"These data support the notion that some patients with CLL are at increased risk to develop severe/critical Covid-19," Montserrat noted. "However, this should not be interpreted as the destiny of [all] CLL patients," he said. He also cautioned that physicians need to carefully weigh the risks and benefits of continuing CLL treatment among patients receiving treatment at the time of Covid-19 diagnosis — "keeping in mind that active, uncontrolled CLL with severe Covid-19 is the worst possible scenario."

In patients who do require treatment, Montserrat recommended the use of ibrutinib as the best treatment option.

"An important caveat is that patients may die not because of Covid-19, but with Covid-19," he pointed out. "Meanwhile, and as long as the Covid-19 outbreak persists, patients with CLL should maintain standard preventive measures… and be managed, wherever possible, in CLL reference centers with Covid-19-free facilities and telemedicine resources," Montserrat advised.

Mato AR, et al "Outcomes of Covid-19 in patients with CLL: A multicenter international experience" Blood 2020; 136(10): 1134-1143.

Montserrat E "When CLL meets Covid-19" Blood 2020; 136(10): 1115-1116.

*New* Article from physician e-news: Red Blood Cell Distribution Width Predicts Covid-19 Death 9/24/2020  - Salynn Boyles, Contributing Writer, BreakingMED™
Reviewed By: Kevin Rodowicz, DO, Assistant Professor, St. Luke’s University/Temple University

Elevated red blood cell distribution width (RDW) measured at hospital admission, and rising RDW during hospitalization were both linked to significantly higher death rates from Covid-19 in a study involving more than 1,600 patients treated at 4 Boston hospitals.

A RDW of greater than 14.5% at the time of hospital admission for illness due to SARS-CoV-2 infection was associated with an almost 3-fold increase in risk for death in the cohort (relative risk [RR] 2.73), with a mortality rate of 31% in these patients, compared to 11% in those with normal RDW.

Among patients younger than 50 years of age, a RDW greater than 14.5% at admission increased the risk for death from Covid-19 more than 5-fold (RR, 5.25), with a mortality rate of 8% vs. 1%, respectively, associated with elevated and normal RDW.

And patients with elevated RDW at hospital admission were more than 6-times more likely to die within 48 hours of admission.

Study findings were published online Sept. 23 in JAMA Network Open.

Red blood distribution width is determined as part of a routine complete blood count test, and elevated RDW, which corresponds to decreased mean red blood cell volume, has been shown in previous studies to be a risk factor for death from all causes, as well as death from heart disease, pulmonary disease, sepsis, cancer, and other life-threatening conditions.

"Previous studies have found evidence in some specific conditions that RDW elevation is caused by delayed clearance of older red blood cells," wrote researcher John M. Higgins, MD, of Massachusetts General Hospital and Harvard Medical School, Boston, and colleagues.

They noted that since red blood cells characteristically decrease in cellular volume across their lifespan, "persistence of these older, smaller cells thus increases volume variance, and this clearance delay coincides with and offsets a net decrease in red blood cell production."

"These reports suggest the possibility that an elevated RDW in some circumstances may reflect a clinical state in which red blood cell production and turnover have slowed in the setting of increased production and turnover of leukocytes or platelets such as would occur in inflammation."

With this background in mind, the researchers examined whether elevated RDW was associated with an increased risk for death among patients hospitalized with Covid-19.

The study included adults admitted for symptoms related to SARS-CoV-2 infection at four Boston hospitals (Massachusetts General Hospital, Brigham and Women’s Hospital, North Sore Medical Center or Newton-Wellesley Hospital) between early March and late April of this year.

Measures included RDW at admission and during hospitalization, with an elevated RDW defined as greater than 14.5%. Relative risk (RR) of mortality was estimated by dividing deaths of those with an elevated RDW by deaths among those without an elevated RDW. Mortality hazard ratios (HRs) and 95% CIs were estimated using a Cox proportional hazards model.

The study population included 1,641 patients (mean [SD] age, 62 [18] years; 886 men [54%]; 740 whites [45%] and 497 Hispanic [30%]; 276 non survivors [17%]).

Elevated RDW (>14.5%) was associated with an increased mortality risk in patients of all ages. A total of 1,173 patients had normal RDW and 468 had elevated RDW. Among patients younger than age 50 years, 341 had normal RDW and 65 had elevated RDW.

Among the main study findings:

·         The relative risk for death associated with elevated RDW compared to normal RDW was 2.73 among the entire cohort, 5.25 among patients younger than age 50 years, 2.90 among patients between the ages of 50 and 59-years, 3.96 among patients between the ages of 60- and 69-years of age, 1.45 among patients who were age 70- to 79, and 1.59 among patients who were age 80 years or older.

·         RDW was associated with mortality risk in Cox proportional hazards models adjusted for age, D-dimer (dimerized plasmin fragment D) level, absolute lymphocyte count, and common comorbidities such as diabetes and hypertension (hazard ratio of 1.09 per 0.5% RDW increase and 2.01 for an RDW >14.5% versus ≤14.5%; P<0.001).

·         Patients whose RDW increased during hospitalization had higher mortality compared with those whose RDW did not change; for those with normal RDW, mortality increased from 6% to 24%, and for those with an elevated RDW at admission, mortality increased from 22% to 40%.

Relative risk for death was particularly elevated within 48 hours of admission, with just 9 of 1,175 patients with normal RDW dying during this time frame (mortality rate, 0.8%) compared to 23 of 479 patients with elevated RDW (morality rate, 4.9%, RR, 6.12).

In addition, risk ratios for different age groups were significantly different compared with each other, suggesting an effect modification, with an elevated RDW having a larger effect on mortality for younger patients (<70 years) than it had for older patients.

Mortality risk associated with RDW remained statistically significant after adjustment for patient age, race, ethnicity, D-dimer level, absolute lymphocyte count, other blood count measures, and 5 major comorbidities.

The researchers concluded that RDW is "a routine laboratory test that may be useful in risk stratification of hospitalized patients with Covid-19."

Foy BH, et al "Association of red blood cell distribution width with mortality risk in hospitalized adults with SARS-CoV-2 infection" JAMA Network Open 2020; 3(9):e2022058.

*Reminder* New Testing Approach

As of Thursday, September 24, all patients who become a COVID PUI after admission to a Med/Surg or ICU bed, all inpatients being COVID tested for discharge, and all inpatients who are tested for COVID for a procedure will have their COVID test done in the hospital lab.

*Reminder* CDC Directive for Optimizing the Supply of N95 Masks

The CDC’s Strategies for Optimizing the Supply of N95 masks were written to follow a continuum using the surge capacity approach in the order of conventional (everyday practice), contingency (expected shortages), and crisis (known shortages) capacities. The CDC developed contingency and crisis strategies to help healthcare facilities conserve their supplies in the face of shortages. CHI Memorial has utilized contingency approach for the usage of N95 masks, in that a mask is to be worn three times and then reprocessed or sterilized.  After evaluation of our current community spread, CHI Memorial will move to a conventional approach to N95 mask usage beginning Monday, September 28, 2020.  That means, N95 masks are to be worn one time and then sent for reprocessing.  This approach will be followed until such time as community spread increases or supplies become constrained.  Please follow current instructions for reprocessing after one use.  

*Reminder* Healthcare Worker Weekend Stay Giveaway

Hotel Indigo Chattanooga Downtown is offering complimentary stays to frontline health care workers as a thank you for their dedicated service. Hotel Indigo will host a healthcare worker and their family or a friend of their choice every weekend from 10/10 through the end of the year. If you know a health care professional who deserves a weekend away, email claire.simmons@hotelindigochatt.com with the full name of the person you are nominating, their place of work, and why they should be chosen. Self-nominations are also permitted. Anyone participating must allow Hotel Indigo to share their story on social media and take a picture with their guest(s) on property to be posted publicly.  This program is ONLY at the Hotel Indigo Chattanooga Downtown and is not applicable to other hotel locations.

*Reminder* Need Hours? Labor Pool Has Openings

There are empty slots available on all campuses. If you can cover a shift at Hixson or Glenwood, please call 495-2294 and for Georgia call 706-858-2761.

Do not judge me by my success, judge me by how many times I fell down and got back up again. – Nelson Mandela

Expanding access to virtual visits for our physicians, APCs, and patients is one of the most important ways we can respond to the public health crisis caused by COVID-19. It is also a critical way that our communities will seek care in the future.

Over the past few months CHI Memorial’s parent corporation, CommonSpirit Health, rapidly expanded the use and adoption of virtual care throughout the Physician Enterprise. Now, as part of an effort to support best practices for the benefit of the communities we serve, a virtual care website (www.CommonSpiritVirtualCare.org) that is accessible to our independent and network physician community has been launched. 

This website includes a comprehensive set of tools and resources to help independent and network physicians adopt a licensed and HIPAA-compliant Zoom platform. The information and training is presented in multiple learning formats and includes:

  • Interactive and document learning
  • Video training
  • Supplemental resources including AMA quick guide to telemedicine, billing and coding best practices, and more

Visit CommonSpiritVirtualCare.org to learn more. 

Physician e-newsletter

Stay current. Save time. MedNews Plus, a free physician e-newsletter, provides breaking medical news by specialty, plus important CHI Memorial news, with the opportunity for nearly 500 hours of AMA PRA Category 1TM CME credit annually. Courtesy of CHI Memorial. Click the link below to log in or subscribe today.

Subscribers will receive a morning email from CHI Memorial's Chief of Staff, when there is breaking medical news in the specialty(s) to which you subscribe. Subscriptions can be edited at anytime.

If you have suggestions for improving this site, please email marketing@memorial.org.