Correct Scoring of Hypopneas in Obstructive Sleep Apnea Reduces Cardiovascular Morbidity

James M. Parish, MD¹

David Baratz, MD²

¹Mayo Clinic Arizona; Phoenix, AZ USA

²Pulmonary Associates, Phoenix, AZ USA

Obstructive Sleep Apnea (OSA) is a life-altering disease with a prevalence of 10% in men and 9% in women (1). In some groups (severe obesity, BMI > 40 kg/m2) the prevalence may be as high as 40% (2). One of the most controversial areas in the field of sleep medicine for many years has been the definition of the syndrome. Investigators who first identified OSA created the apnea index (AI), the number of apnea events per hour. An apnea was defined as a complete cessation of airflow for at least 10 seconds. When continuous positive airway pressure (CPAP) treatment for OSA was first introduced, a definition that third-party payors, such as the Center for Medicare and Medicaid Services (CMS), could use to determine which patients qualified for treatment was needed. The definition at that time was 30 apnea events during a 6-hour recording, which corresponded to an AI of 5 events per hour. As further information developed about the syndrome of OSA, the presence of the hypopnea was recognized. A hypopnea was an event that was not a complete cessation of airflow, but rather was a reduction in airflow associated with either a reduction of oxygen saturation and/or an arousal from sleep. Hypopneas were found to have the same clinical significance as apneas. However, controversy surrounded the exact definition of hypopnea. What percentage reduction in airflow? What degree of desaturation, 3%, 4%, other? (3) And what was the exact definition of arousal? Additionally, at this time, CMS would not recognize the use of hypopneas in the definition of OSA for the purpose of qualifying patients for the use of CPAP and a result, many patients with predominantly hypopneas did not meet the qualifications for CPAP.

Subsequently, an agreement between the sleep community and CMS was reached utilizing the definition of hypopnea of a reduction of airflow to 30% of baseline and a 4% oxygen desaturation (4). This definition was based on findings from the Sleep Heart Health Study demonstrating significant cardiovascular effects in patients with obstructive sleep apnea/hypopnea syndrome utilizing this definition. The association of hypopnea with arousal was left out of this definition at this time because there was poor reproducibility in scoring. While the benefit of this agreement was the inclusion of hypopneas which allowed more patients to qualify for PAP therapy, there was a large group of individuals with hypopneas with 3% desaturation and/or an arousal who did not meet the criteria for therapy.

In 2012 the American Academy of Sleep Medicine (AASM) recommended that the hypopnea definition include any decrease in airflow by at least 30% from the baseline with an oxygen desaturation of at least 3% or an arousal from sleep (5,6). This definition often forced many sleep laboratories to score studies twice, once using the 3% rule and the other using the 4% rule. The 3%-4% controversy has continued for many years.

Since then CMS and other payors has not adopted the recommendation of the AASM primarily because of lack of evidence that a 3% decrease is associated with cardiovascular disease and relied on a more restrictive definition of OSA fewer patients with OSA (as defined by the AASM) have been able to obtain life changing therapy such as CPAP. In the view of many, this has increased the risk of developing cardiovascular disease.

In this issue of SWJPCC an article by Quan et al., “The Association Between Obstructive Sleep Apnea Defined by 3 Percent Oxygen Desaturation or Arousal Definition and Self-Reported Cardiovascular Disease in the Sleep Heart Health Study” demonstrates that employing a definition of hypopnea utilizing a 3% reduction in the oxygen desaturation results in an equivalent incidence of cardiovascular disease (CVD) or coronary heart disease (CHD) as the more restrictive 4% definition (7). The shows that in patients followed in the Sleep Heart Health Study (SHHS) that 6307 participants developed CVD/CHD at equal rates based on odds ratios and 95% confidence intervals.  The SHHS was a prospective multicenter cohort study designed to investigate the relationship between OSA and CVD (8).  6441 subjects 40 years and older were recruited in 1995 to undergo polysomnography, having demographic information taken and then self-report if they were ever told by a doctor that they had angina, heart attack, heart failure, stroke or undergone coronary bypass surgery or coronary angioplasty. CHD or CVD was defined as a positive response to one or more of these conditions or procedures. In addition, the presence of hypertension, diabetes, depression, insomnia and hypersomnia in these subjects was assessed.

In this current analysis of the SHHS 3326 participants were found not to have OSA by the 4% CMS rule. Using the 3% AASM definition of hypopnea, 2247 of the 3326 participants were found to have OSA. Participants that were not diagnosed by the 4% rule had OSA ranging in the mild to severe categories. This study suggests that the regulatory requirement by the CMS of using a 4% decrease in oxygen desaturation denies a substantial number of patients the opportunity for treatment of their OSA and may worsen cardiovascular disease or coronary heart disease.

This paper is the first to assess the association of the 3% criteria in the risk of developing CVD/CHD in patients with OSA. The importance of this paper cannot be underestimated.  There are no other studies that have been done or are being done that investigate the risk between OSA or cardiovascular disease using polysomnographic measurements. By utilizing the 3% rule in clinical practice a much larger number of patients would meet the diagnostic criteria of OSA and be eligible to receive treatment.

Treatment of OSA with CPAP has been shown to reduce the severity of CVD, CHD, diabetes, motor vehicle accidents. It also improves daytime alertness, concentration, emotional stability, reduces snoring, and reduces medical expenses (9-11).

The current study provides the necessary information to help resolve the ongoing controversy. The studies data is very robust, using the well-known Sleep Heart Health study. A limitation of the study is that it relies on self-reported history of cardiovascular disease, which is subject to recall bias, but the data is otherwise very strong and robust. Also, some of the correlations are less statistically significant when adjusted for other co-variates.

This study provides proof that a large number of patients with symptomatic and dangerous OSA have been undertreated. It calls for a change in the policy by the CMS and all other payors to provide therapy for patients with OSA based on the American Academy of Sleep Medicine criteria using a 3% reduction in oxygen saturation to score hypopneas.

References

1. Peppard PE, Young T, Barnet JH, Palta M, Hagen EW, Hla KM. Increased prevalence of sleep-disordered breathing in adults. Am J Epidemiol. 2013 May 1;177(9):1006-14. [CrossRef] [PubMed]
2. Rajala R, Partinen M, Sane T, Pelkonen R, Huikuri K, Seppäläinen AM. Obstructive sleep apnoea syndrome in morbidly obese patients. J Intern Med. 1991 Aug;230(2):125-9. [CrossRef] [PubMed]
3. Redline S, Sanders M. Hypopnea, a floating metric: implications for prevalence, morbidity estimates, and case finding. Sleep. 1997 Dec;20(12):1209-17. [CrossRef] [PubMed]
4. Meoli AL, Casey KR, Clark RW, Coleman JA Jr, Fayle RW, Troell RJ, Iber C; Clinical Practice Review Committee. Hypopnea in sleep-disordered breathing in adults. Sleep. 2001 Jun 15;24(4):469-70. [PubMed]
5. Anonymous. CPAP for Obstructive Sleep Apnea Updated 2020. https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/CPAP. 
6. Berry RB, Budhiraja R, Gottlieb DJ, Gozal D, Iber C, Kapur VK, Marcus CL, Mehra R, Parthasarathy S, Quan SF, Redline S, Strohl KP, Davidson Ward SL, Tangredi MM; American Academy of Sleep Medicine. Rules for scoring respiratory events in sleep: update of the 2007 AASM Manual for the Scoring of Sleep and Associated Events. Deliberations of the Sleep Apnea Definitions Task Force of the American Academy of Sleep Medicine. J Clin Sleep Med. 2012 Oct 15;8(5):597-619. [CrossRef] PMID: [PubMed]
7. Quan SF, Budhiraja R, Javaheri S, Parthasarathy S, Berry RB. The Association Between Obstructive Sleep Apnea Defined by 3 Percent Oxygen Desaturation or Arousal Definition and Self-Reported Cardiovascular Disease in the Sleep Heart Health Study. Southwest J Pulm Crit Care. 2020;21(4):86-103. [PubMed]
8. Quan SF, Howard BV, Iber C, Kiley JP, Nieto FJ, O'Connor GT, Rapoport DM, Redline S, Robbins J, Samet JM, Wahl PW. The Sleep Heart Health Study: design, rationale, and methods. Sleep. 1997 Dec;20(12):1077-85. [PubMed]
9. Javaheri S, Barbe F, Campos-Rodriguez F, Dempsey JA, Khayat R, Javaheri S, Malhotra A, Martinez-Garcia MA, Mehra R, Pack AI, Polotsky VY, Redline S, Somers VK. Sleep Apnea: Types, Mechanisms, and Clinical Cardiovascular Consequences. J Am Coll Cardiol. 2017 Feb 21;69(7):841-858. [CrossRef] [PubMed]
10. McEvoy RD, Antic NA, Heeley E, Luo Y, Ou Q, Zhang X, Mediano O, Chen R, Drager LF, Liu Z, Chen G, Du B, McArdle N, Mukherjee S, Tripathi M, Billot L, Li Q, Lorenzi-Filho G, Barbe F, Redline S, Wang J, Arima H, Neal B, White DP, Grunstein RR, Zhong N, Anderson CS; SAVE Investigators and Coordinators. CPAP for Prevention of Cardiovascular Events in Obstructive Sleep Apnea. N Engl J Med. 2016 Sep 8;375(10):919-31. [CrossRef] [PubMed].
11. Anonymous. CPAP – Benefits and Health Risk Prevention. AASM. Sleep Education. 2015, Aug. 10. Available at: http://sleepeducation.org/essentials-in-sleep/cpap/benefits (accessed 10/18/20).

Cite as: Parish JM, Baratz D. Correct Scoring of Hypopneas in Obstructive Sleep Apnea Reduces Cardiovascular Morbidity. Southwest J Pulm Crit Care. 2020;21(4):104-7. doi: https://doi.org/10.13175/swjpcc059-20 PDF

Trump’s COVID-19 Case Exposes Inequalities in the Healthcare System

Early Friday morning (October 2, 2020) President Trump announced through Twitter that he had tested positive for COVID-19 (aka SARS-CoV-2). Later Friday afternoon he was whisked away by helicopter for a 10-minute ride to Walter Reed National Military Medical Center (WRNMMC, formerly Bethesda Naval Medical Center) which is across the street from the National Institutes of Health campus in Bethesda. There he received REGN-COV2, a combination of two monoclonal antibodies (REGN10933 and REGN10987) directed against the spike protein of the COVID-19 virus. In addition, he received a dose of remdesivir (an antiviral drug) as well as zinc, vitamin D, famotidine (Pepcid®), melatonin and aspirin. As of Saturday morning, Trump has done well by all accounts.

All the therapies administered to Trump are unproven but have some evidence supporting their use against COVID-19. The Trump administration issued an emergency use authorization for remdesivir earlier this year after the drug showed moderate effectiveness in improving outcomes for patients who were hospitalized with the coronavirus (1). REGN-COV2 is now in Phase 3 clinical trials, is still experimental and has not received emergency use approval from the FDA. However, it had sufficient evidence for President Trump to receive the drug in response to a compassionate use request to the manufacturer (2). There is also some evidence that the other ancillary therapies might be useful therapies against COVID-19 (3-7).

What these therapies have in common is that the available scientific evidence of their efficacy was funded, at least in part, by the US government, most prominently the FDA’s Coronavirus Treatment Acceleration Program (CTAP) (8). The US government has spent several billion dollars on COVID-19 therapies including $450 million on REGN-COV2 and at least $75 million for remdesivir (9,10). The success of the program is remarkable in light of the disbanding of the National Security Council pandemic unit which had predicted the disaster we are now enduring (11). The ingenuity of the scientific community is truly amazing when motivated by billions of dollars. Those Americans who actually pay taxes should be proud of their government officials for making such successful investments on their behalf.

President Trump’s care is in contrast to my own or the general public. I recently became ill with increasing shortness of breath, orthopnea and a nonproductive cough but no fever. Because I have a history of diastolic dysfunction, I had assumed this was heart failure. As a physician who has many friends in the medical community, I am privileged to be able to call my cardiologist who saw me later that day. The general public might well have had to accept his next available appointment which was over 3 months or go to an emergency room. After 2 days, and 5 trips to a free-standing radiology center and 2 trips to a laboratory testing site, it became clear that I had left lower pneumonia by chest-x-ray and a normal brain naturetic peptide. Later that day I went to a free-standing clinic and had a rapid COVID-19 test which was negative. Because my presentation was atypical for bacterial pneumonia, I called my pulmonary physician who also saw me later that day. He ordered a coccioidomycosis serology and a COVID-19 test by PCR. The former because of the high possibility of Valley Fever which can cause up to a third of community-acquired pneumonias in Arizona and the latter because of the poor sensitivity of the rapid COVID-19 antibody test (12,13). However, I was not able to schedule the collection of the nasal swab or blood for 10 days at a free-standing laboratory. This seems excessively long and my pulmonologist decided against empirical treatment for Valley Fever because of a potential drug interaction with one of my heart medications (dofetilide).

President Trump often brags that the US has the greatest healthcare system in the world and for him it is. Although he repeatedly touted ineffective therapies for COVID-19 such as hydroxychloroquine, bleach and light and belittled those who wore masks, when he got sick only scientifically based therapy was used despite the expense (14). The general public probably does not have President Trump’s or my access to physicians. Donald Trump, the White House staff, and some professional athletes are getting daily COVID-19 tests but the rest of us taxpayers are forced to wait 10 days to get a nasal swab and a blood sample drawn.

USA Today is now reporting that President Trump had earned capital gains from Regeneron Pharmaceuticals and Gilead Sciences, the manufacturers of REGN-COV2 and remdesivir (15). According to a 2017 financial disclosure form filed with the U.S. Office of Government Ethics in June 2017, Trump had a capital gain of $50,001 to $100,000 for Regeneron Pharmaceuticals and $100,001 to $1 million for Gilead. Trump’s subsequent disclosure forms, including his 2020 form signed July 31, did not list Regeneron or Gilead. Ostensibly, he, other family members and close associates sold their stocks to avoid any apparent conflict of interest.

Based on previous experience, I remain skeptical that therapies developed and distributed by our tax monies will really be free. Will the clever businessmen who run drug companies take money from the US government for product development and then bill a hefty sum for their product? Will the rush to develop a vaccine before the November elections put expediency over safety? Some vaccines rushed to market such as the polio vaccine of 1955 or the swine flu vaccine of 1976 resulted in serious side effects in some recipients (16). As Trump is so fond of saying, “We will have to wait and see”.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. FDA. COVID-19 Update: FDA Broadens Emergency Use Authorization for Veklury (remdesivir) to Include All Hospitalized Patients for Treatment of COVID-19. August 28, 2020. Available at: https://www.fda.gov/news-events/press-announcements/covid-19-update-fda-broadens-emergency-use-authorization-veklury-remdesivir-include-all-hospitalized#:~:text=Today%2C%20as%20part%20of%20its,laboratory%2Dconfirmed%20COVID%2D19%2C (accessed 10/3/20).
2. Farr C, Stankiewicz K. Here’s everything we know about the unapproved antibody drug Trump took to combat coronavirus. CNBC. October 2, 2020. Available at: https://www.cnbc.com/2020/10/02/what-we-know-about-regeneron-antibody-drug-trump-took-to-combat-coronavirus.html (accessed 10/3/20).
3. Arentz S, Yang G, Goldenberg J, et al. Clinical significance summary: Preliminary results of a rapid review of zinc for the prevention and treatment of SARS-CoV-2 and other acute viral respiratory infections [published online ahead of print, 2020 Aug 1]. Adv Integr Med. 2020;10.1016/j.aimed.2020.07.009. [CrossRef] [PubMed]
4. Entrenas Castillo M, Entrenas Costa LM, Vaquero Barrios JM, Alcalá Díaz JF, López Miranda J, Bouillon R, Quesada Gomez JM. "Effect of calcifediol treatment and best available therapy versus best available therapy on intensive care unit admission and mortality among patients hospitalized for COVID-19: A pilot randomized clinical study". J Steroid Biochem Mol Biol. 2020 Oct;203:105751. [CrossRef] [PubMed]
5. Freedberg DE, Conigliaro J, Wang TC, Tracey KJ, Callahan MV, Abrams JA; Famotidine Research Group. Famotidine Use Is Associated With Improved Clinical Outcomes in Hospitalized COVID-19 Patients: A Propensity Score Matched Retrospective Cohort Study. Gastroenterology. 2020 Sep;159(3):1129-1131.e3. [CrossRef] [PubMed]
6. Zhang R, Wang X, Ni L, et al. COVID-19: Melatonin as a potential adjuvant treatment. Life Sci. 2020;250:117583. [CrossRef] [PubMed]
7. Mohamed-Hussein AAR, Aly KME, Ibrahim MAA. Should aspirin be used for prophylaxis of COVID-19-induced coagulopathy? Med Hypotheses. 2020 Jun 8;144:109975. [CrossRef] [PubMed]
8. FDA. Coronavirus Treatment Acceleration Program (CTAP). Available at: https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap (accessed 10/3/20).
9. Loftus P, Walker J.  U.S. Commits $2 Billion for Covid-19 Vaccine, Drug Supplies. Wall Street Journal. July 7, 2020. Available at: https://www.wsj.com/articles/u-s-commits-2-billion-for-covid-19-vaccine-drug-supplies-11594132175 (accessed 10/3/20).
10. Public Citizen. The Public Already Has Paid for Remdesivir. Available at: https://www.citizen.org/news/the-public-already-has-paid-for-remdesivir/ (accessed 10/3/20).
11. Riechmann D. Trump disbanded NSC pandemic unit that experts had praised. AP News. March 14, 2020. Available at: https://apnews.com/article/ce014d94b64e98b7203b873e56f80e9a (accessed 10/3/20).
12. Valdivia L, Nix D, Wright M, Lindberg E, Fagan T, Lieberman D, et al. Coccidioidomycosis as a common cause of community-acquired pneumonia. Emerg Infect Dis. 2006;12(6):958-62. [CrossRef] [Pubmed]
13. Guglielmi G. Fast coronavirus tests: what they can and can't do. Nature. 2020 Sep;585(7826):496-498. [CrossRef] [PubMed]
14. Robbins RA. Lack of natural scientific ability. Southwest J Pulm Crit Care. 2020;21(1):15-22. [CrossRef]
15. Tyko K. Trump COVID-19 treatment: President had stakes in Regeneron and Gilead, makers of antibody cocktail, Remdesivir. USA Today. October 3, 2020. Available at: https://www.usatoday.com/story/money/2020/10/03/trump-walter-reed-treatment-president-regeneron-gilead-remdesivir/3610111001/ (accessed 10/3/20).
16. Trogen B, Oshinsky D, Caplan A. Adverse Consequences of Rushing a SARS-CoV-2 Vaccine: Implications for Public Trust. JAMA. 2020 Jun 23;323(24):2460-2461. [CrossRef] [PubMed]

Cite as: Robbins RA. Trump’s COVID-19 Case Exposes Inequalities in the Healthcare System. Southwest J Pulm Crit Care. 2020;21(4):82-5. doi: https://doi.org/10.13175/swjpcc055-20 PDF 

Lack of Natural Scientific Ability

Back in March President Trump suggested he would have thrived in another profession, medical expert (1). Despite no training or experience, Trump boasted “I like this stuff. I really get it”. Citing a “great, super-genius uncle” who taught at MIT, Trump professed that it must run in the family genes. Trump went on to say “People are really surprised I understand this stuff … Maybe I have a natural ability.”

This was followed by a series of White House briefings where Trump and members of his White House Coronavirus Task Force spoke on the COVID-19 pandemic. Trump tried to dominate these conferences and repeatedly lied about the coronavirus pandemic and the country’s preparation for this once-in-a-generation crisis. Below is a partial list of 35 of the biggest lies about the COVID-19 pandemic he’s told as the nation endures a public-health and economic calamity are in Table 1 (2). 

Table 1. Partial list of Trump lies regarding the COVID-19 pandemic (2).

Date	Trump claim	Truth
2/7/20	The coronavirus would weaken “when we get into April, in the warmer weather—that has a very negative effect on that, and that type of a virus.”	Respiratory viruses can be seasonal, but the COVID-19 can be transmitted in ALL AREAS, including areas with hot and humid weather and is clearly not diminishing.
2/27/20	The outbreak would be temporary: “It’s going to disappear. One day it’s like a miracle—it will disappear.”	Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, warned days later that he was concerned that “as the next week or two or three go by, we’re going to see a lot more community-related cases.”
Multiple times	The claim: If the economic shutdown continues, deaths by suicide “definitely would be in far greater numbers than the numbers that we’re talking about” for COVID-19 deaths.	The number of people who died by suicide in the US in 2017 was roughly 47,000, nowhere near the COVID-19 deaths now at about 147,000 (3).
Multiple times	“Coronavirus numbers are looking MUCH better, going down almost everywhere,” and cases are “coming way down.”	Most states now have rising COVID-19 cases, hospitalizations and deaths (3).
7/2/20	The pandemic is “getting under control.”	Most states now have rising COVID-19 cases, hospitalizations and deaths (3). It is not under control.
7/4/20	“99%” of COVID-19 cases are “totally harmless.”	The evidence shows that the virus “can make you seriously ill” even if it doesn’t kill you
7/6/20	“We now have the lowest Fatality (Mortality) Rate in the World.”	The U.S. has neither the lowest mortality rate nor the lowest case-fatality rate (3).
3/4/20	“The Obama administration made a decision on [laboratory] testing that turned out to be very detrimental to what we’re doing.”	The Trump White House rolled back Food and Drug Administration regulations that limited the kind of laboratory tests states could run and how they could conduct them.
3/13/20	The Obama White House’s response to the H1N1 pandemic was “a full scale disaster, with thousands dying, and nothing meaningful done to fix the testing problem, until now.”	Barack Obama declared a public-health emergency two weeks after the first U.S. cases of H1N1 were reported, in California. Trump declared a national emergency more than seven weeks after the first domestic COVID-19 case was reported, in Washington State. While testing is a problem now, it wasn’t back in 2009. The challenge then was vaccine development: Production was delayed and the vaccine wasn’t distributed until the outbreak was already waning.
Multiple times	The Trump White House “inherited” a “broken,” “bad,” and “obsolete” test for the coronavirus.	The novel coronavirus did not exist in humans during the Obama administration.
Multiple times	The Obama administration left Trump “bare” and “empty” shelves of medical supplies in the national strategic stockpile.	The stockpile’s former director said in 2019, before the coronavirus pandemic, that it was well-equipped. The outbreak has since eaten away at its reserves.
5/10/20	Trump attacked “Joe Biden’s handling of the H1N1 Swine Flu.”	Biden was not responsible for the federal government’s response to the H1N1 outbreak.
3/6/20 & 5/11/20	“Anybody that needs a test, gets a test. We—they’re there. They have the tests. And the tests are beautiful” and “If somebody wants to be tested right now, they’ll be able to be tested.”	Trump made these two claims two months apart, but the truth is still the same: The U.S. does not have enough testing.
3/24 & 3/25/20	The United States has outpaced South Korea’s COVID-19 testing: “We’re going up proportionally very rapidly,” Trump said during a Fox News town hall.	When the president made this claim, testing in the U.S. was severely lagging behind that in South Korea. As of March 25, South Korea had conducted about five times as many tests as a proportion of its population relative to the United States.
5/11/20	America has “developed a testing capacity unmatched and unrivaled anywhere in the world, and it’s not even close.”	The United States is still not testing enough people and is lagging behind the testing and tracing capabilities that other countries have developed.
Multiple times	“Cases are going up in the U.S. because we are testing far more than any other country.”	COVID-19 cases are not rising because of “our big-number testing.” Outside the Northeast, the share of tests conducted that come back positive is increasing, with the sharpest spike happening in southern states. In some states, such as Arizona and Florida, the number of new cases being reported is outpacing any increase in the states’ testing ability. And as states set new daily case records and report increasing hospitalizations, all signs point to a worsening crisis.
3/11/20	The United States would suspend “all travel from Europe, except the United Kingdom, for the next 30 days.”	The travel restriction would not apply to U.S. citizens, legal permanent residents, or their families returning from Europe.
3/12/20	All U.S. citizens arriving from Europe would be subject to medical screening, COVID-19 testing, and quarantine if necessary. “If an American is coming back or anybody is coming back, we’re testing,” Trump said. “We have a tremendous testing setup where people coming in have to be tested … We’re not putting them on planes if it shows positive, but if they do come here, we’re quarantining.”	Testing was already severely limited in the United States at the time Trump made this claim. It was not true that all Americans returning to the country are being tested, nor that anyone is being forced to quarantine.
3/31/20	“We stopped all of Europe” with a travel ban. “We started with certain parts of Italy, and then all of Italy. Then we saw Spain. Then I said, ‘Stop Europe; let’s stop Europe. We have to stop them from coming here.’”	The travel ban applied to the Schengen Area, as well as the United Kingdom and Ireland, and not all of Europe as he claimed.
Multiple times	“Everybody thought I was wrong” about implementing restrictions on travelers from China, and “most people felt they should not close it down—that we shouldn’t close down to China.”	The travel ban was the “uniform” recommendation of the Department of Health and Human Services.
Multiple times	travel restrictions on China were a “ban” that closed up the “entire” United States and “kept China out.”	Nearly 40,000 people traveled from China to the United States from February 2, when Trump’s travel restrictions went into effect, to April 4.
3/17/20	I’ve always known this is a real—this is a pandemic. I felt it was a pandemic long before it was called a pandemic … I’ve always viewed it as very serious.”	Trump has repeatedly downplayed the significance of COVID-19 as outbreaks began stateside. From calling criticism of his handling of the virus a “hoax,” to comparing the coronavirus to a common flu, to worrying about letting sick Americans off cruise ships because they would increase the number of confirmed cases, Trump has used his public statements to send mixed messages and sow doubt about the outbreak’s seriousness.
3/26/20	This kind of pandemic “was something nobody thought could happen … Nobody would have ever thought a thing like this could have happened.”	Experts both inside and outside the federal government sounded the alarm many times in the past decade about the potential for a devastating global pandemic.
3/2/20	Pharmaceutical companies are going “to have vaccines, I think, relatively soon.”	The president’s own experts told him during a White House meeting with pharmaceutical leaders earlier that same day that a vaccine could take a year to 18 months to develop.
3/19/20	Trump said the FDA had approved the antimalarial drug chloroquine to treat COVID-19. “Normally the FDA would take a long time to approve something like that, and it’s—it was approved very, very quickly and it’s now approved by prescription,” he said.	FDA Commissioner Stephen Hahn quickly clarified that the drug still had to be tested in a clinical setting.
3/23/20	Trump suggested in a briefing on April 23 that his medical experts should research the use of powerful light and injected disinfectants to treat COVID-19.	Trump walked this statement back the next day, saying he was being “sarcastic”.
5/8/20	The coronavirus is “going to go away without a vaccine … and we’re not going to see it again, hopefully, after a period of time.”	Tony Fauci has said that until there is “a scientifically sound, safe, and effective vaccine” the pandemic will not be over.
Multiple times	Taking hydroxychloroquine to treat COVID-19 is safe. “You’re not going to get sick or die,” Trump said on one occasion. “It doesn’t hurt people,” he commented on another.	Trump’s own FDA has warned against taking the antimalarial drug with or without the antibiotic azithromycin, which Trump has also promoted.
5/9/20	“One bad” study from the Department of Veterans Affairs that found no benefit among veterans who took hydroxychloroquine to treat COVID-19 was run by “people that aren’t big Trump fans.” The study “was a Trump-enemy statement.”	There’s no evidence that the study was a political plot orchestrated by Trump opponents, and it reached similar conclusions as other observational reports. The VA study was led by independent researchers from the University of Virginia and the University of South Carolina with a grant from the National Institutes of Health.
3/20/20	Trump twice said during a task-force briefing that he had invoked the Defense Production Act (DPA), a Korean War–era law that enables the federal government to order private industry to produce certain items and materials for national use. He also said the federal government was already using its authority under the law: “We have a lot of people working very hard to do ventilators and various other things.”	Federal Emergency Management Agency Administrator Peter Gaynor told CNN on March 22 that the president has not actually used the DPA to order private companies to produce anything. Shortly after that, Trump backtracked, saying that he had not compelled private companies to take action. Then, on March 24, Gaynor told CNN that FEMA plans to use the DPA to allocate 60,000 test kits. Trump tweeted afterward that the DPA would not be used.
3/21/20	Automobile companies that have volunteered to manufacture medical equipment, such as ventilators, are “making them right now.”	Ford and General Motors, which Trump mentioned at a task-force briefing the same day, announced earlier in March that they had halted all factory production in North America and were likely months away from beginning production of ventilators.
3/24/20	Governor Andrew Cuomo of New York passed on an opportunity to purchase 16,000 ventilators at a low cost in 2015, Trump said during the Fox News town hall.	Trump seems to have gleaned this claim from a Gateway Pundit article. There is no evidence that Cuomo was offered the ventilators or turned any offer down.
3/29/20	Trump “didn’t say” that governors do not need all the medical equipment they are requesting from the federal government. And he “didn’t say” that governors should be more appreciative of the help.	Trump told Fox News’ Sean Hannity on Thursday, March 26, that “a lot of equipment’s being asked for that I don’t think they’ll need,” referring to requests from the governors of Michigan, New York, and Washington. He also said, during a Friday, March 27, task-force briefing, that he wanted state leaders “to be appreciative … We’ve done a great job.”
3/29 and 3/30/20	Hospitals are reporting an artificially inflated need for masks and equipment, items that might be “going out the back door,” Trump said on two separate days. He also said he was not talking about hoarding: “I think maybe it’s worse than hoarding.”	There is no evidence to show that hospitals are maliciously hoarding or inflating their need for masks and personal protective equipment when reporting shortages in supplies.
4/14/20	Asked about his past praise of China and its transparency, Trump said that he hadn’t “talk[ed] about China’s transparency.”	Trump lauded the country in tweets he sent in late January and early February. In one, he highlighted the Chinese government’s “transparency” about the coronavirus outbreak.
3/29/20	WHO ignored “credible reports” of the coronavirus’s spread in Wuhan, the Chinese city that first reported the new virus, including those published in The Lancet medical journal in December.	The Lancet said it did not publish such reports in December. Its first reports on the virus’s spread in Wuhan were published on January 24.

Trump eventually stopped the news briefings in face of their declining popularity and public trust and being outshone by Tony Fauci MD, director of National Institute of Allergy and Infectious Disease. Fauci is best known as an expert virologist for his handling of the Acquired Immunodeficiency Disease Syndrome (AIDS). He has faithfully served his patients, the American people, through six presidential administrations, providing sound, science‐based guidance. However, he has been wrong. Two examples are not recommending masks early in the COVID-19 pandemic and stating that few COVID-19 patients were asymptomatic (4). However, both were based on the best available scientific evidence of the time which turned out to be wrong. In neither instance was Fauci’s honesty questioned and, in both instances, Fauci self-corrected those errors.

The strained relationship between the White House and Fauci has been apparent for months. Trump was visibly annoyed when Fauci spoke at news briefings (5). In April Trump retweeted a call to fire Fauci during early criticism of Trump’s mishandling of the COVID-19 pandemic (6). He has attempted to silence Fauci’s inconvenient scientific voice from testifying before Congress and giving TV interviews (7). More recently, he has tried an old tactic of having aides and underlings attack opponents and then evaluating how it plays with the public. If it goes well Trump repeats it, but if it does not, he says the aide was acting on his own. The White House let their top economic advisor, Peter Navarro, attack Fauci in an USA Today op-ed (8). Last Sunday, White House scientific advisor Brett Girori MD tried to undermine Fauci last Sunday on Meet the Press saying Fauci only looks at the COVID-19 pandemic from “a very narrow public health point of view”; doesn’t “have the whole national interest in mind’; and repeated the White House opposition to Fauci’s call for states experiencing COVID-19 surges to pause their reopening processes (9).

The attacks against Fauci were apparently unsuccessful. Referring to the White House attacks, Fauci remained calm saying, “I cannot figure out in my wildest dreams why they would want to do that” (10). New polling from Quinnipiac University found that 65% of voters trust the information Fauci is providing about the coronavirus while only 30% trust the information provided by Trump (11). In the face of the polls favorable to Fauci, the White House is now distancing itself from Navarro saying he went rogue failing to obtain proper clearance for his op-ed (12).

In a closely related event, the Trump Administration has mandated that hospitals sidestep the Centers for Disease Control and Prevention and send critical information about COVID-19 hospitalizations and equipment to a different federal database (13). From the start of the pandemic, the CDC has collected data on COVID-19 hospitalizations, availability of intensive care beds and personal protective equipment. The change sparked concerns that the administration was hobbling the ability of the nation's public health agency to gather and analyze crucial data in the midst of a pandemic. It further allows data to be manipulated, altered or spun for political purposes. The decision raises serious questions about the credibility, transparency, and availability of data needed by public health officials, researchers, and physician leaders to advance science-based and data-driven decision-making. The White House has lied enough to show they cannot be trusted with data needed for responses to the COVID-19 pandemic such as reopening.

The scientific data is what it is. It has no philosophy, no politics, and is often not what we want it to be. During this pandemic which is the most catastrophic public health disaster since the “Spanish Flu” of 1918, we need scientific leadership to ensure that the data is driving our responses and not being driven by a political agenda. Leaders like Tony Fauci are needed for this pandemic. Others who attempt to undermine Fauci for their own nefarious political purposes will hopefully be ignored by the public. Nonscientific wags who claim scientific abilities they do not have do not really get it. They will likely lead us towards a cataclysmic catastrophe that could be diminished with sensible decisions made on the basis of science rather than politics.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Nakamura D. ‘Maybe I have a natural ability’: Trump plays medical expert on coronavirus by second-guessing the professionals. Washington Post. March 6, 2020. Available at:  https://www.washingtonpost.com/politics/maybe-i-have-a-natural-ability-trump-plays-medical-expert-on-coronavirus-by-second-guessing-the-professionals/2020/03/06/3ee0574c-5ffb-11ea-9055-5fa12981bbbf_story.html (accessed 7/17/20).
2. Paz C. All the president’s lies about the coronavirus. The Atlantic. July 13, 2020. https://www.theatlantic.com/politics/archive/2020/07/trumps-lies-about-coronavirus/608647/ (accessed 7/17/20).
3. Coronavirus Resource Center. Johns Hopkins University. Available at: https://coronavirus.jhu.edu/ (accessed 7/17/20).
4. Panetta G. Fauci says he doesn't regret telling Americans not to wear masks at the beginning of the pandemic. Business Insider. Jul 16, 2020. Available at: https://www.businessinsider.com/fauci-doesnt-regret-advising-against-masks-early-in-pandemic-2020-7 (accessed 7/17/20).
5. Lahut J. Trump is reportedly getting frustrated with Dr. Fauci's 'blunt approach' during White House press conferences. Business Insider. Mar 23, 2020. Available at: https://www.businessinsider.com/trump-reportedly-growing-frustrated-with-dr-faucis-blunt-approach-2020-3 (accessed 7/17/20).
6. Brewster J. Trump retweets call to fire Fauci after he criticized U.S. response to virus. April 13, 2020. Available at: https://www.forbes.com/sites/jackbrewster/2020/04/13/trump-retweets-call-to-fire-fauci-after-he-criticized-us-response-to-virus/#47860ca451d6 (accessed 7/17/20).
7. Pramuk J. White House blocks Fauci from testifying at House coronavirus hearing. CNBC. May 1, 2020. Available at: https://www.cnbc.com/2020/05/01/anthony-fauci-blocked-from-testifying-at-house-coronavirus-hearing.html (accessed 7/17/20).
8. Navarro P. Anthony Fauci has been wrong about everything I have interacted with him on. USA Today. July 14, 2020. Available at: https://www.usatoday.com/story/opinion/todaysdebate/2020/07/14/anthony-fauci-wrong-with-me-peter-navarro-editorials-debates/5439374002/ (accessed 7/17/20).
9. Meet the Press. July 12, 2020. https://www.nbcnews.com/meet-the-press/video/adm-brett-grior-dr-fauci-is-not-100-percent-right-about-covid-19-response-87536197610 (accessed 7/17/20).
10. Nicholas P, Yong E. 1.        Fauci: ‘Bizarre’ White House Behavior Only Hurts the President. July 15, 2020. Available at: https://www.theatlantic.com/politics/archive/2020/07/trump-fauci-coronavirus-pandemic-oppo/614224/ (accessed 7/17/20).
11. Stelter B. New poll reaffirms that most Americans don't trust the President, but they do trust Dr. Fauci. CNN Business. July 16, 2020. Available at: https://www.cnn.com/2020/07/15/media/poll-trump-fauci-reliable-sources/index.html (accessed 7/17/20).
12. Samuels B. White House distances itself from Navarro op-ed bashing Fauci. The Hill. 07/15/20. Available at: https://thehill.com/homenews/administration/507406-white-house-distances-itself-from-navarro-op-ed-bashing-fauci (accessed 7/17/20).
13. Huang P, Simmons-Duffin S.  White House strips CDC of data collection role for COVID-19 hospitalizations. NPR. July 15, 2020. https://www.npr.org/sections/health-shots/2020/07/15/891351706/white-house-strips-cdc-of-data-collection-role-for-covid-19-hospitalizations (accessed 7/17/20).

Cite as: Robbins RA. Lack of natural scientific ability. Southwest J Pulm Crit Care. 2020;21(1):15-22. doi: https://doi.org/10.13175/swjpcc044-20 PDF 

What the COVID-19 Pandemic Should Teach Us

As I write this between telemedicine patients on June 16^th, I am reflecting back on the pandemic and what we have learned so far, not in how to diagnose or care for the COVID-19 patients, but in government and healthcare administration’s response to the pandemic.

Politicians have made both good and poor decisions regarding the COVID-19 pandemic. In the summer of 2005, President George W. Bush was on vacation at his ranch in Crawford, Texas, when he began flipping through an advance reading copy of a new book about the 1918 influenza pandemic (1). He couldn't put it down. What was born was the nation's most comprehensive pandemic plan -- a playbook that included diagrams for a global early warning system, funding to develop new, rapid vaccine technology, and a robust national stockpile of critical supplies, such as face masks and ventilators. Bush’s remarks from 15 years ago still resonate. "If we wait for a pandemic to appear," he warned, "it will be too late to prepare. And one day many lives could be needlessly lost because we failed to act today."

In what will probably go down as some of the worse timing in history, the Trump administration eliminated or severely cut funding to these Bush-era programs (2). In March of 2018, Timothy Ziemer, whose job it was to lead the United States response in the event of a pandemic, abruptly left the administration and his global health security team was disbanded. In February 2020 the administration released its proposed federal budget proposal for fiscal year 2021, calling for a cut of more than $693 million at the Centers for Disease Control and Prevention, as well as a $742 million cut to programs at the Health Resources and Services Administration. Overall, the president’s budget proposed a 9% funding cut at the U.S. Department of Health and Human Services. More recently the US has pulled out of the World Health Organization with the dubious timing of being in the middle of this pandemic. In addition, Trump downplayed the pandemic from the beginning and has ignored the advice of virtually every epidemiologist encouraging “opening up” the country ignoring accelerating COVID-19 cases and death tolls (2,3).

In Arizona early in the pandemic we were doing OK with most businesses shut down and people by and large staying at home. Our clinic was closed although we continued to see telemedicine patients. However, Governor Ducey, under the apparent urging of Trump, “opened up” the state beginning May 15 resulting in an apparent resurgence of COVID-19 cases. No word from Ducey, the Arizona State Department of Health Services or Maricopa Health and Human Services on how we should respond to the resurgence. I cannot find any admission by any of the governors, and certainly not Trump, that states that prematurely “opened up” was a mistake.

Misinformation is everywhere. Everyone with a computer and no or inadequate medical education has suddenly become an expert in COVID-19. My inbox is flooded with multiple emails from people I do not know espousing their latest theories, guidelines, unproven treatments, or passing along the latest internet COVID-19 chatter.

This disinformation is potentially dangerous but the scientific community has also made mistakes. For example, a controversial study led by Didier Raoult from Marseilles on the combination of hydroxychloroquine and azithromycin for patients with COVID-19 was published March 20 (4). It showed a reduction in viral load and “clinical improvement compared to the natural progression.” This was picked by several including Trump who claimed to be taking hydroxychloroquine as a preventative. Papers purporting to show that hydroxychloroquine was ineffective were published in the New England Journal of Medicine and the Lancet. These have been retracted since the database from which they were derived was found to be unreliable (5). These studies have only added to the confusion of hydroxychloroquine’s effectiveness in COVID-19.

Government and hospitals were unprepared. In 2009, a smaller pandemic due to H1N1 swept through the United States (6). Ventilators, ICU beds, and adequate numbers of healthcare providers were in short supply despite the Bush administration’s attempt at preparedness (7). When the pandemic resolved no additional preparations were made for another and larger pandemic. Disturbingly, when the current COVID-19 pandemic occurred there were inadequate numbers of ventilators for patients and inadequate protection for healthcare workers. In some instances, personal protective equipment was not allowed to be used (8). There was no response from the federal government or hospitals. What could they do? They needed the physicians and nurses to care for the tidal wave of patients exposing the healthcare workers to COVID-19. To date about 600 healthcare workers have died during the COVID-19 pandemic and it will likely go much higher.

Healthcare hyperfinancializaton was the source for the unpreparedness. The source of this unpreparedness at both the national and local level was a desire to save money since a pandemic was viewed by decision makers as unlikely in the near future. Cutting taxes and maximizing profits were the real goals and preparation for a pandemic was not viewed as a priority especially since it interfered with the real goal of making money. We are now paying the price for these short-sighted decisions. Since the federal government has markedly increased the federal debt with a COVID-19 bailout, we will likely continue to pay the price with higher taxes and/or by cutting other government programs viewed as low priorities. Some of these programs may prove to be as potentially valuable as the trashed pandemic plan.

As a country we need to start thinking about how to approach these decisions in the future. In my view, the present system of politicians and businessmen serving as healthcare decision makers has been an abysmal failure. The COVID-19 pandemic is but one example of this failure. Clearer heads both in government and healthcare regulation such as the Joint Commission need to become more concerned that the voices of knowledgeable people such as Tony Fauci are heard. Until we develop such a system, we can anticipate healthcare to be unprepared for calamities such as the COVID-19 pandemic they occur in the future.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Mosk M. George W. Bush in 2005: 'If we wait for a pandemic to appear, it will be too late to prepare'. A book about the 1918 flu pandemic spurred the government to action. ABC News. April 5, 2020. Available at: https://abcnews.go.com/Politics/george-bush-2005-wait-pandemic-late-prepare/story?id=69979013 (accessed 6/16/20).
2. Morris C. Trump administration budget cuts could become a major problem as coronavirus spreads. Fortune. February 26, 2020. Available at: https://fortune.com/2020/02/26/coronavirus-covid-19-cdc-budget-cuts-us-trump/ (accessed 6/16/20).
3. Fadel L. Public health experts say many states are opening too soon to do so safely. NPR. Weekend Edition. May 9, 2020. Available at: https://www.npr.org/2020/05/09/853052174/public-health-experts-say-many-states-are-opening-too-soon-to-do-so-safely (accessed 6/16/20).
4. Gautret P, Lagier JC, Parola P, et al. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial [published online ahead of print, 2020 Mar 20]. Int J Antimicrob Agents. 2020;105949. [CrossRef] [PubMed]
5. Gumbrecht J, Fox M. Two coronavirus studies retracted after questions emerge about data. CNN. June 4, 2020. Available at: https://www.cnn.com/2020/06/04/health/retraction-coronavirus-studies-lancet-nejm/index.html (accessed 6/16/20).
6. CDC. 2009 H1N1 pandemic (H1N1pdm09 virus). Available at: https://www.cdc.gov/flu/pandemic-resources/2009-h1n1-pandemic.html (accessed 6/16/20).
7. WHO. Shortage of personal protective equipment endangering health workers worldwide. Available at: https://www.who.int/news-room/detail/03-03-2020-shortage-of-personal-protective-equipment-endangering-health-workers-worldwide (accessed 6/16/20).
8. Sathya C. Why would hospitals forbid physicians and nurses from wearing masks? Sci Am. March 26, 2020. Available at: https://blogs.scientificamerican.com/observations/why-would-hospitals-forbid-physicians-and-nurses-from-wearing-masks/ (accessed 6/17/20).

Cite as: Robbins RA. What the COVID-19 pandemic should teach us. Southwest J Pulm Crit Care. 2020;20(6):192-4. doi: https://doi.org/10.13175/swjpcc042-20 PDF 

Improving Testing for COVID-19 for the Rural Southwestern American Indian Tribes

Arshia Chhabra¹

Varinn Sood²

Vanita Sood, MD³

Akshay Sood, MD, MPH^4,5

¹La Cueva High School, 7801 Wilshire Ave NE, Albuquerque, NM USA

²Albuquerque Academy, 6400 Wyoming Blvd. NE, Albuquerque, NM USA

³Andrew Weil Center for Integrative Medicine, University of Arizona, 655 N Alvernon Way, Tucson, AZ USA;

⁴Department of Internal Medicine, University of New Mexico Health Sciences Center, Albuquerque, NM USA; ⁵Black Lung Program, Miners’ Colfax Medical Center, Raton, NM, USA.

Coronavirus disease 2019 (COVID-19) is caused by the severe acute respiratory syndrome-related coronavirus-2 (SARS–CoV-2) infection. The United States (US) currently has more officially reported cases and deaths from COVID-19 than any other country in the world. The rural Southwestern American Indian (SAI) tribes are disproportionately affected, due to genetics, immunological naivety, social determinants of health, and high prevalence of concomitant comorbidities and co-exposures (1). On March 30, 2020, the New Mexico Governor, Michelle Lujan Grisham, informed the US President Donald Trump of the “incredible spikes” in cases of COVID-19 within the Navajo Nation in the rural Four Corners region of the American Southwest (2). The Governor warned that the disease “... could wipe out those tribal nations.”

Use of COVID-19 testing as an approach to combating the pandemic is supported by an Iceland-based epidemiological study, and endorsed by the World Health Organization (3). Rural states in the US rank higher in prevalence of COVID-19 risk factors (hypertension, obesity, and diabetes), but rank lower in overall testing rates (4). Notably, several Southwestern states such as Arizona, Texas and Oklahoma have among the lowest testing rates in the country (5). Taken together, these results suggest that the current COVID-19 surveillance does not effectively capture medically vulnerable rural populations in the Southwest (4). Testing in the SAI tribal communities is further limited by the following reasons: 1) misinformation on tests due to the lack of broadband Internet access; 2) inadequate access to test sites due to lack of transportation and long travel distances; 3) traditional mistrust of the healthcare system; 4) concern about mishandling of biological samples; 5) misunderstanding that molecular assays interpret the genetic structure of the virus and not their people; 6) difficulty paying for the tests; and 7) nationwide shortage of test kits. Buy-in from community leaders and traditional healers, utilizing culturally sensitive communications, and access to broadband Internet are crucial to improving effective testing-based surveillance in these communities.

A large number of molecular and serological tests for COVID-19 are currently available, many of which lack evaluation data. Molecular tests, useful for establishing a diagnosis, utilize respiratory tract specimens to assess for the presence of nucleic acid targets specific to SARS–CoV-2 using the reverse transcriptase-polymerase chain reaction (RT-PCR) or nucleic acid amplification assays. RT-PCR–based assays performed in the laboratory on nasopharyngeal swabs collected by trained professionals are currently the cornerstone of COVID-19 diagnostic testing. Most RT-PCR assays take a few hours to complete, but the Cepheid assay has shortened the test duration to 45 minutes (6). Recent molecular tests such as CRISPR-Case12-based lateral flow assay and Abbott ID Now™, utilizing isothermal nucleic acid amplification technology for the qualitative detection of viral RNA have shortened the turnaround time further (7). Unlike molecular tests, serological tests may be useful in public health surveillance and vaccine evaluation, but not as the sole test for diagnosing the acute stage of the disease (8). Performed on blood specimens, serological tests use formats such as enzyme-linked immunosorbent assay and rapid lateral flow immunoassay, to detect immunoglobulin M (IgM) and/or immunoglobulin G (IgG) antibodies, which are produced by the body at approximately 10 days and 20 days respectively following COVID-19 infection. Current molecular and serological tests are laboratory-based and not easily available in the SAI tribal settings.

Living far away from hospitals, rural SAI residents need easy access to sample collection venues.  Across the world, many different sample collection venues can serve as useful prototypes, which includes drive-through-, booth-, mobile laboratory-, and home-based approaches. The latter approach involves the use of self-test kits, which are ideal. The approach involves kits containing instructions for testees to self-collect nasal swabs (or possibly early morning salivary specimens (9)) for molecular tests, or finger-stick blood samples for serologic tests. The FDA recently granted emergency clearance to the first at-home molecular test, a nasal self-swab kit (Pixel, LabCorp, USA), with a mail-back to the company laboratory for conducting the PCR assay, with online access to the results (10).

Although not currently available, the ideal test for the SAI tribal settings is low cost, less complex, point of care, rapid (i.e., test turn-around time preferably within an hour), and able to be performed by non-laboratory professionals in low-infrastructure settings, such as homes. The test results could be potentially uploaded to a mobile app or be viewed over a telemedicine consultation to interpret the results and provide immediate counseling on the next step. Smartphone-based devices containing a cartridge-housed microfluidic chip, which carries out isothermal amplification of viral nucleic acids from nasal swab samples in 30 minutes, which are detected using the smartphone camera, may soon be available for home testing (11). Rapid point of care serologic tests, similar to finger-stick blood glucose tests, and home pregnancy tests with colorimetric reading, mal also soon become available for home testing (12).To take advantage of rapid point-of-care testing that will soon become available, improving access to smartphones and broadband Internet in SAI tribal communities is crucial.

The primary goal of the pandemic containment in the rural SAI tribal communities is to reduce the basic reproductive number (R0, the expected number of cases directly generated by one case) of the SARS–CoV-2 virus, thereby reducing disease transmission. Given the lack of effective vaccines or treatments, the only currently available levers to reduce SARS–CoV-2 transmission are to practice social isolation, universal masking, and hand hygiene, identify asymptomatic and symptomatic infected cases through ideal testing strategies, and isolate contagious persons (8). Although not currently available, the ideal test for SAI communities is point of care, rapid, and home-based and requires efforts to improve access to smartphones and broadband Internet. Testing can be popularized using community leaders and traditional indigenous care providers. Finally, policy solutions are needed to eliminate financial barriers for uninsured or underinsured patients, to help meet the goal of improving testing-based COVID-19 surveillance in the rural SAI tribal communities.

References

1. Kakol M, Upson D, Sood A. Susceptibility of southwestern american Indian tribes to coronavirus disease 2019 (COVID-19). J Rural Health. 2020. [CrossRef] [PubMed]
2. Faulders K, Rubin O. New Mexico's governor warns tribal nations could be 'wiped out' by coronavirus, https://abcnews.go.com/Politics/mexicos-governor-warns-tribal-nations-wiped-coronavirus, published March 30, 2020,  accessed on April 3, 2020: ABC news (online); 2020.
3. Gudbjartsson DF, Helgason A, Jonsson H, Magnusson OT, Melsted P, Norddahl GL, et al. Spread of SARS-CoV-2 in the Icelandic population. N Engl J Med. 2020 Apr 14.  [Epub ahead of print] [CrossRef] [PubMed]
4. Souch JM, Cossman JS. A commentary on rural-urban disparities in covid-19 testing rates per 100,000 and risk factors. J Rural Health. 2020 Apr 13. [Epub ahead of print] [CrossRef] [PubMed]
5. Monnat SM. Why coronavirus could hit rural areas harder. Available at https://lernercenter.syr.edu/2020/03/24/why-coronavirus-could-hit-rural-areas-harder/.  Printed March 24, 2020. Accessed March 26, 2020. Learner Center for Health Promotion.
6. Xpert®Xpress SARS-CoV-2. Available online: https://www.cepheid.com/coronavirus. March 21,2020. (accessed on 2 April 2020).
7. Abbott Launches Molecular Point-of-Care Test to Detect Novel Coronavirus in as Little as Five Minutes. Available online: https://abbott.mediaroom.com/2020-03-27-Abbott-Launches-Molecular-Point-of-Care-Test-to-Detect-Novel-Coronavirus-in-as-Little-as-Five-Minutes.  March 27, 2020. (accessed on 2 April 2020)
8. Cheng MP, Papenburg J, Desjardins M, Kanjilal S, Quach C, Libman M, et al. Diagnostic testing for severe acute respiratory syndrome-related coronavirus-2: a narrative review. Ann Intern Med. 2020 Apr 13. [Epub ahead of print] [CrossRef] [PubMed]
9. To KK, Tsang OT, Leung WS, Tam AR, Wu TC, Lung DC, et al. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study. Lancet Infect Dis. 2020 May;20(5):565-74. [CrossRef] [PubMed]
10. LabCorp. Pixel by LabCorp, COVID-19 At-Home Kits. Available at https://www.pixel.labcorp.com/covid-19. Accessed April 23, 2020.
11. Sun F, Ganguli A, Nguyen J, Brisbin R, Shanmugam K, Hirschberg DL, et al. Smartphone-based multiplex 30-minute nucleic acid test of live virus from nasal swab extract. Lab Chip. 2020 May 5;20(9):1621-7. [CrossRef] [PubMed]
12. Vashist SK. In vitro diagnostic assays for covid-19: recent advances and emerging trends. Diagnostics (Basel). 2020 Apr 5;10(4). pii: E202. [CrossRef] [PubMed]

Cite as: Chhabra A, Sood V, Sood V, Sood A. Improving testing for COVID-19 for the rural Southwestern American Indian tribes. Southwest J Pulm Crit Care. 2020;20(5):175-8. doi: https://doi.org/10.13175/swjpcc037-20 PDF