September 22, 2020

WHISTLING THE COLLEGE HORNPIPE

September 22, 2020

In the novel David Copperfield by Charles Dickens, Mister Micawber gave young Copperfield a piece of advice that may exceed in prescience the cumulative wisdom of all treatises ever written on the subject of home economics.

“Annual income twenty pounds, annual expenditure nineteen nineteen six, result happiness.
Annual income twenty pounds, annual expenditure twenty pounds ought and six, result misery.

The blossom is blighted, the leaf is withered, the God of day goes down upon the dreary scene, and-and in short you are for ever floored. As I am.”

In order to underscore the grave and serious nature of his contention, Mr. Micawber then drank a glass of punch with an air of great enjoyment and satisfaction, and whistled the college hornpipe.

As shown in 2020 because of COVID-19, excessive debt can be ruinous, destroying households and business enterprises alike. Government in the U.S. at state and local levels also has been devastated by debt. Meanwhile, along lines of whistling the college hornpipe the federal government continues to thrive despite adding trillions of dollars to an ever growing mountain of debt that already exceeded 20 trillion dollars at the beginning of this year. The difference is that Congress can appropriate funding for emergency purposes while the Federal Reserve can purchase debt instruments, lower interest rates, and print money.

Even when Congress is unable to reach agreement on additional sources of pandemic-related funding, as mentioned in the previous issue of this newsletter, the nation’s president can sign executive orders that influence the flow of money and other policies. During the month of August 2020, President Donald Trump released a series of orders that include: a payroll tax deferral for workers, provision of weekly federal jobless benefits, expansion of a congressionally-approved eviction moratorium that expired in July 2020, relief for student borrowers, increased access to telehealth, support for rural hospitals, and the production of more drugs made in America while loosening federal drug-safety and environmental regulations that are perceived as placing domestic producers at a disadvantage.

Similar to previous years when Congress is unable to complete work on 13 separate appropriation bills by the start of a new fiscal year each October 1, to avoid an impending shutdown one or more short-term continuing resolutions (CRs) are implemented. Currently envisioned is a stopgap spending measure that would be effective until December 11. Despite it being an election year that will reduce the amount of time available to pass other bills while House and Senate members are on the campaign trail, the House Energy and Commerce Committee was able to consider 26 health bills during a September 9 markup that involved expanding access to mental health services, combating the opioid epidemic, and reauthorizing key public health programs. The vast majority of more than 8,349 House bills (1,037 for health) and 4,656 Senate bills (585 for health) introduced in the 116th Congress as of September 22, 2020 will not be passed and enacted, but could be reintroduced beginning next year.

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A QUASI-CATEGORICAL DEMURRAL

Kristen Truong

September 22, 2020

Harvard University Professor Arthur Scheslinger, Jr. served as a special assistant and “court historian” to President John Kennedy until the latter’s death in November 1963. Two years later, his book “A Thousand Days: John F. Kennedy in the White House” was published. Around that same time, when interviewed he was asked to assess the impact of the Kennedy presidency. He easily could have stated that it still is too soon to offer a complete assessment, but instead he indicated that it was best to characterize the situation as a quasi-categorical demurral.

While recognizing it may be highly unlikely that many individuals would express their views in this kind of parlance, for the sake of argument let’s assume for the purpose of the following brief disquisition that the professor’s use of this terminology can be applied constructively to COVID-19 and its imagined aftermath. As indicated by an article on page five of this issue of TRENDS, more than 100,000 scientific publications already have been published about the coronavirus, but until it runs its final course, presumably any satisfying definitive analysis will have to remain a work in progress for the nonce.

The purported necessity of closing down a major portion of the U.S. economy, the largest in the world, is a topic that undoubtedly will attract considerable attention. One aspect certainly will include whether deleterious health impacts, such as increases in child/intimate partner abuse, alcohol/drug substance use/abuse, suicidal ideation, homelessness, and lost educational opportunities for students ultimately proved to be more devastating than COVID-19 itself.

Closer to home regarding the academic community, some insights are provided by an editorial published in the August 29, 2020 issue of the British medical journal The Lancet. For example, the pandemic is undermining the ability of researchers to do their jobs and of universities to provide a high-quality and safe educational experience for students. Moreover, the pandemic will have complex, unexpected, and long-term implications for research that must be anticipated now. Essential pillars are under threat, such as a workforce with the skills, training, experience, relationships, and networks needed for research excellence; necessary resources, including funding; and multidisciplinary perspectives supported by science. Spending on education and research is threatened by economic downturns with academic budgets squeezed by COVID-19, jeopardizing jobs and research funding.

An effective vaccine soon may become available. According to information appearing in the August 29-September 4, 2020 issue of The Economist, the pollster YouGov reveals that only 37% of Republicans and 61% of Democrats say they would be vaccinated for COVID-19. The figure is barely 30% for middle-aged and less-educated individuals on the right end of the political spectrum. Not only in the U.S., but among other nations “anti-vaxx” sentiments have many followers who are even more distrustful about vaccine safety and effectiveness than U.S. residents. Hence, while there is value in looking ahead to a time when this coronavirus disappears, it essentially remains much too soon to understand its full impact.

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PRESIDENT’S CORNER

Kristen Truong

August 27, 2020

Some Reflections On The Health Workforce In A Time Of Pandemic

Surges of COVID-19 patients have influenced state officials across the nation to take numerous steps to remove health workforce barriers. An example is a significant expansion of scopes of practice for various clinicians who were and are being educated today in institutions belonging to ASAHP, e.g., physical therapists, occupational therapists, respiratory therapists, and speech‐language pathologists. Other key changes have included:

Allowing some students in professions, such as medicine and nursing, to perform services they are competent to provide by lessening restrictions involving education requirements.
Granting temporary licenses or allowing certain kinds of students to provide services without a license.
Suspending prohibitions that prevent clinicians from other states from providing care via telemedicine.

Advances in technology will influence how health care services are delivered. For example, articles in issues of the journal Science Robotics in July 2020 and in the July/August 2020 issue of MIT’s Technology Review discuss the enhanced potential for the use of assistive robots during infectious disease outbreaks. Hospitals in Texas are using them to help nurses with tasks involving disinfection, patient intake, and delivery of supplies, such as laboratory samples, intravenous pumps, medications, and protective gear during the current pandemic. As technological developments progress, it becomes increasingly likely that robots not only will assist, but might even replace health workers in the performance of other routine tasks.

As described in an a manuscript in the November 2020 issue of the journal Addictive Behaviors, the COVID-19 pandemic has resulted in unprecedented stress on health care systems throughout the world. Health care workers are bearing the burden of caring for those afflicted with COVID-19, a consequence of which is direct and sustained infection risk. As essential workers are compelled to confront these increased infection risks, they also are faced with a risk of experiencing higher rates of stress from the pandemic.

A tool recently developed that is called COVID Stress Scales categorizes stressors from the pandemic into five categories: danger and contamination fear, social and economic stress, traumatic stress symptoms, checking and reassurance seeking behavior, and xenophobia. In the general population, each factor can contribute to increased substance use and abuse risk. Also of significance is that these factors can be compounded in essential workers, placing this group at particularly high risk for these problems.

This constellation of stressors is viewed as warranting unique programs of intervention to manage drug use and abuse. Research to develop such programs is needed, particularly in consideration of the broad impact of COVID-19. Researchers are encouraged to tackle these important issues systematically in preparation for challenges that individuals may face with substance use and abuse in the face of current pandemic-related circumstances, post-COVID-19, and for future pandemics. It also would seem prudent for faculty members who provide instruction for and clinical supervision of health professions students to consider ways in which education programs can assist these individuals in being better prepared to meet the challenges of working in highly stressful circumstances when they enter the workplace.

TV and the Internet have provided vivid examples of many different kinds of allied health professionals leaving the safety of their homes to commute via public transportation to furnish care for patients in hospitals who are being treated for COVID-19 infection. They place their own lives at risk in order to save the lives of individuals stricken with this disease. Today’s children are witnesses to the efforts being made by these first responders to help others who are less fortunate. It is worth pondering the extent to which these images will inspire the youth of today to desire to become part of the future health workforce.

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AUTOPSIES, HEALTH DISPARITIES, AND INFORMED CONSENT

Kristen Truong

August 25, 2020

A popular ingredient in stories of crime in movies and television programs is the defining moment when a detective and the pathologist are able to solve a puzzling death based on autopsy findings. In contrast to forensic autopsies mandated by law, clinical autopsies are performed to clarify diagnoses. Rates of the latter procedure have declined from a high of 19% (1950s-1970s) to 8% (2007). This decrease is related to financial, legal, and administrative disincentives, along with perceptions that diagnostic improvements render autopsies obsolete. Patient and caregiver factors also may be related to declining rates. Across all conditions, black individuals had a significantly higher rate of autopsies compared with white individuals (difference between races: 0.9% in cancer and 5.6% in cardiovascular disease). According to an item published on June 29, 2020 in the journal JAMA Internal Medicine, it is hypothesized that the higher rate of autopsies in black decedents may reflect health disparities. Less-aggressive diagnostic workups in black patients may translate into less-established diagnoses before death, possibly associated with the rates of autopsies. The higher rate also could reflect altruism, obtaining autopsies for the promotion of science, and perhaps even may represent caregivers wanting to know the “real cause of death,” suggesting mistrust of the health care system.

Another element that may be of some interest is that pathologists likely will incorporate genetic testing into routine autopsies. An article published in the June 2020 issue of the Archives of Pathology & Laboratory Medicine poses the question, should specific consent for genetic autopsy testing be required? An individual consenting to an autopsy should know that genetic testing will be performed and may lead to information that directly will have an impact on the decedent’s family, e.g., an increased risk of untreatable neurodegenerative disease. The author indicates that the person giving informed consent for the autopsy needs to know, understand the benefits, limitations, and alternatives of genetic testing and be able to refuse genetic testing in a private autopsy. Clearly, details of how best to obtain consent for genetic testing in autopsies is a needed area for future discussion and clarification.

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RACIAL DISPARITIES AND NOMENCLATURE IN NEUROSCIENCE

Kristen Truong

August 25, 2020

Minority racial groups are exposed differentially to environmental risk factors (e.g., early life adversity) that are known to play a role in a variety of psychiatric disorders. According to a paper in the July 2020 issue of the journal Neuropsychopharmacology, a significant potential for racial disparities in environmental risk factors to moderate the relationship between neurobiology and psychiatric disorder development currently is unexplored. Early life events, such as childhood trauma, maternal stress, immune system activation, and other risk factors show clear effects on the neural substrates of emotion and stress regulation. Minority racial groups also have lower family income and wealth, and often live in areas with greater disadvantage compared with non-minority racial groups. Recent research further suggests minority racial groups have increased exposure to toxins throughout life which can have potentially deleterious effects on physical and mental health. Racial discrimination also can be damaging psychologically and further alter the neurobiology of psychiatric disorders.

Viewed from a different perspective, neuropsychiatric symptoms are a core feature of Alzheimer’s disease and related dementias. Successful information exchange between clinicians and family caregivers is critical for facilitating effective management of these symptoms. This communication often is challenging, however, due to inconsistent terminology and classification of symptoms, and limited understanding of how family caregivers recognize and describe symptoms. A study reported in the August 2020 issue of the journal The Gerontologist examined the language family caregivers’ use to describe and contextualize neuropsychiatric symptoms. Family caregivers of patients with dementia use a wide range of terminology in their descriptions. Their nomenclature and sense-making appear to contrast with clinical and research classification of neuropsychiatric symptoms that is predominantly deficit-oriented. Thus, reliance on effective communication between caregivers and their clinical teams for effective symptom management may require adopting caregivers’ language or explicit development of shared nomenclature.

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AVAILABLE RESOURCES ACCESSIBLE ELECTRONICALLY

Kristen Truong

August 25, 2020

Sharing Clinical Trial Data: Challenges And A Way Forward

Responsible sharing of clinical trial data is widely recognized as serving the public interest. Data sharing helps maximize the contributions to scientific knowledge made by clinical trial participants, benefiting patients today and in the future. Clinical trial data sharing can enable reproducibility of research findings, analyses for other areas of study, and exploratory work to generate new research hypotheses. While progress has been made in the endeavor of improving clinical trial data sharing, challenges still remain. On November 18 and 19, 2019, the National Academies of Sciences, Engineering, and Medicine hosted a public workshop, in Washington, DC, titled “Sharing Clinical Trial Data: Challenges and a Way Forward.” The workshop followed the release of the 2015 Institute of Medicine (IOM) consensus study, Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risks, and was designed to examine the current state of clinical trial data sharing and reuse since the report release. The workshop considered ways in which policy, technology, incentives, and governance could be leveraged to overcome remaining barriers and further facilitate data sharing. These proceedings summarize presentations and points made at the workshop in 2019 and can be obtained here.

The 2015 consensus study can be obtained here.

National Inpatient Hospital Costs: The Most Expensive Conditions By Payer, 2017

A Statistical Brief from the Agency for Healthcare Research and Quality (AHRQ) presents data from the Healthcare Cost and Utilization Project (HCUP) on costs of hospital inpatient stays in the United States using the 2017 National Inpatient Sample (NIS). It describes the distribution of costs by primary expected payer and illustrates the conditions accounting for the largest percentage of each payer's hospital costs. Hospital charges were converted to costs using HCUP Cost-to-Charge Ratios. The expected payers examined are Medicare, Medicaid, private insurance, and self-pay/no charge. Because of the large sample size of the NIS data, small differences can be statistically significant. Thus, only differences greater than or equal to 10% are noted in the text. Hospital costs in this Statistical Brief represent the hospital's costs to produce the services, not the amount paid for services by payers, and they do not include separately billed physician fees associated with the hospitalization. Healthcare spending in the United States increased 4.2% between 2016 and 2017 to $3.5 trillion, or $10,739 per person, and accounted for 17.9% of the Gross Domestic Product. Constituting nearly one-third of all healthcare expenditures, hospital spending rose 4.7% to $1.1 trillion during the same time period. Although this growth represented deceleration compared with the 5.8% increase between 2014 and 2015, the consistent year-to-year rise in hospital-related expenses remains a central concern among policymakers. In 2016, there were over 35 million hospital stays, equating to 104.2 stays per 100,000 population. The average cost per hospital stay was $11,700, making hospitalization one of the most expensive types of healthcare utilization. Higher costs are documented for stays among patients with an expected payer of Medicare compared with stays with other expected payers ($13,600 for Medicare vs. $9,300-$12,600 for other payers). The Brief can be obtained here.

Racial and Ethnic Disparities Among COVID-19 Cases in Workplace Outbreaks

Data from the Morbidity and Mortality Weekly Report of August 21, 2020 show that during March 6–June 5, 2020, workplace outbreaks occurred in 15 Utah industry sectors; 58% of workplace outbreak-associated COVID-19 cases were in three sectors: Manufacturing, Wholesale Trade, and Construction. Despite representing 24% of Utah workers in all affected sectors, Hispanic and nonwhite workers accounted for 73% of workplace outbreak-associated COVID-19 cases. The report can be obtained here.

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QUICK STAT (SHORT, TIMELY, AND TOPICAL)

Kristen Truong

August 25, 2020

The COVID-19 Pandemic And Exacerbation Of Physical Intimate Partner Violence

During the COVID-19 pandemic, social distancing and stay-at-home orders have been enacted throughout the world to stop disease transmission and keep individuals safe, but for victims of intimate partner violence (IPV), being quarantined with an abuser means that home may be the most dangerous place to be. In a study published on August 13, 2020 in the journal Radiology, a team led by investigators at Brigham and Women's Hospital in Boston assessed the incidence, pattern, and severity of injuries related to IPV in patients at the facility during the spring of 2020. The researchers found that the incidence of physical abuse IPV and severity of injuries was greater during the pandemic. They also observed a higher incidence of victims of high-risk abuse, including strangulation, use of weapons, stab, and burns. A conclusion reached is that radiologists and other health care providers should proactively participate in identifying IPV victims and reach out to vulnerable communities as an essential service during the pandemic and other crises.

Mental Health, Substance Use, And Suicidal Ideation During The Coronavirus Pandemic

As indicated on August 14, 2020 in the Morbidity and Mortality Weekly Report, during June 24–30, 2020, U.S. adults reported considerably elevated adverse mental health conditions associated with COVID-19. These conditions are affecting specific populations disproportionately, especially young adults, Hispanic persons, black persons, essential workers, unpaid caregivers for adults, and those receiving treatment for preexisting psychiatric conditions. These individuals are experiencing disproportionately worse mental health outcomes, increased substance use, and elevated suicidal ideation. Unpaid caregivers for adults, many of whom are currently providing critical aid to persons at increased risk for severe illness from COVID-19, had a higher incidence of adverse mental and behavioral health conditions compared with others. Although unpaid caregivers of children were not evaluated in this study, approximately 39% of unpaid caregivers for adults shared a household with children (compared with 27% of other respondents).

HEALTH TECHNOLOGY CORNER

Digital Biomarker Of Diabetes From Smartphone-Based Vascular Signals

Smartphone-based photoplethysmography (PPG) provides a readily attainable, non-invasive digital biomarker of prevalent diabetes. According to an article published on August 17, 2020 in the journal Nature Medicine, PPG is a non-invasive optical technique that detects blood flow changes through a vascular bed. It involves shining light into tissue, such as the fingertip or wrist, and quantifying the backscattered light that corresponds with changes in blood volume. Until recently, PPG recording required specialized equipment, however, technological developments have enabled PPG measurement from sensors on smart devices, such as smartphones. Researchers at the University of California San Francisco developed this biomarker to detect Type 2 diabetes, one of the world's top causes of disease and death, potentially providing a low-cost, in-home alternative to blood draws and clinic-based screening tools. Type 2 diabetes can raise the risk of diseases affecting nearly every organ system, including coronary heart disease.

Using Smartphone Accelerometers To Sense Gait Impairments Due To Alcohol Intoxication

Sensing alcohol intoxication in real time could offer opportunities for triggering just-in-time interventions aimed at improving prevention and treatment of alcohol use disorders. In a laboratory study described on August 18, 2020 in the Journal of Studies on Alcohol and Drugs, researchers found that smartphones can capture unique gait features that are sensitive to alcohol intoxication, classifying it within individuals with an accuracy of around 90%. The findings extend prior published research examining the use of phone sensors to detect gait changes related to alcohol. Despite acknowledged limitations, this proof-of-concept study provides a foundation for future research on using smartphones to detect alcohol-related impairments remotely. Current tools to measure alcohol consumption and/or impairment remotely either require the purchase of additional hardware or the burden of manual recording of consumption. A mobile application could be built to sense periods of walking, measure accelerometer signals, and when sway patterns are recognized, trigger either just-in-time support or use further techniques to improve classification further.

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DEVELOPMENTS IN HIGHER EDUCATION

Kristen Truong

August 25, 2020

Education administrators at levels ranging from pre-K to colleges and universities, along with public health officials throughout the U.S., continue to observe their best laid plans being stymied by a virus known as COVID-19 that refuses to conform to expectations. Some higher education officials decided that if instruction were to be provided during the fall semester, it would be offered electronically instead of in classrooms. Other administrators were willing to admit students, but had a backup plan ready that would enable a rapid conversion to online education either for a certain number of weeks or for the entire semester in the event a spike in infections occurred. Installing hygienic measures on school grounds and promoting social distancing policies were viewed as measures that would allow students to return safely. Unfortunately, for some college students the urge to socialize and attend large parties both on- and off-campus has contributed to a rise in the number of individuals becoming infected with the coronavirus. Even if extraordinary efforts have been made for a campus to be a safe environment, off-campus gatherings and the arrival of students each day who do not reside on school property are examples of the major challenges involved in efforts to achieve and maintain high standards of hygiene.

Financial Aspects Of An Inability To Be On Campus And Attend Classes

A major item in the budgets of a great many families with college-age offspring is the costs of higher education. Factors such as tuition, room and board, and activity fees often are beyond reach from the standpoint of being able to finance them out-of-pocket. Assistance in the form of loans has become a necessity. Whether students ever graduate within six years, and many of them never do, with and without degrees they are saddled with substantial loans that will take many years of payments before their debt is settled. Accordingly, many families currently are unwilling to pay on-campus rates, particularly when education has shifted to online instruction because of the pandemic. Some institutions have responded by reducing tuition rates for courses offered online or by offering to defer payment until the fall semester in 2021. Meanwhile, litigation moves forward throughout the U.S. by students and families seeking to obtain refunds for unoccupied dormitories and unused food serve halls that were closed in the spring semester when students were compelled to leave campus after the coronavirus emerged as a serious threat.

Addressing The Need And The Demand For Mental Health Services For Students

Even before the appearance of COVID-19 earlier this year, many campus mental health centers were unable to provide assistance to the large number of students who sought help for conditions, such as depression and high anxiety. Currently, most of these same individuals are at home and they are joined by other students who find it difficult to cope with the strains imposed by social lockdowns and worries about what the future may have in store for them. As this infectious disease subsides and the economy achieves a fuller recovery, millions of unemployed workers will be eager to return to whatever old jobs still exist or seek new opportunities. Recent graduates and the class of 2021 may find it difficult to compete with that group of recently displaced individuals. As depicted on page six of the July-August 2020 issue of this newsletter, the Morbidity and Mortality Weekly Report for August 14 of this year indicates that younger adults in the 18-24 age group are among the groups reported having experienced disproportionately worse mental health outcomes, increased substance use, and elevated suicidal ideation. College-age students that are part of this cohort may benefit through telehealth interventions emanating from campus, but the quality of assistance could vary from what occurs in face-to-face encounters in a clinical setting.

Expansion Of Educational Opportunities For Students

An announcement from the U.S. Department of Education on August 19, 2020 describes a new grant program designed to help institutions of higher education emerge from the coronavirus pandemic more resilient and better able to expand educational opportunities for students. The grants can be used in a variety of ways that include resuming operations, supporting students, reducing disease transmission, and developing more agile instructional delivery models for students who cannot or choose not to attend classes in person. This program also recognizes the benefits to high school students of starting their college career early, while still in high school, and gives priority to applicants who plan to expand those opportunities to students who live or attend high school in an Opportunity Zone or rural community. More information can be obtained here.

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LEGISLATION VS. EXECUTIVE ORDERS

Kristen Truong

August 24, 2020

Given its size (535 members), complexity of a broad range of legislative issues, partisan differences, and conflicting views between the two chambers, Congress sometimes proves to be an unwieldy place to produce bills that can be forwarded to the President of the U.S. to be signed into law. Currently, the presence of the coronavirus that is ravaging portions of the population creates a sense of urgency in dealing with important problems involving both health care and the economy. Whenever nettlesome situations occur in governance and action must be taken, it is not unusual for Presidents to rely on producing executive orders instead of continuing to wait for legislative solutions to emerge.

During the month of August 2020, President Donald Trump exercised that option by releasing a series of orders after Congress was unable to reach agreement on a new coronavirus relief package. Democrats in the House previously had approved a $3 trillion bill and offered to lower the amount to $2 trillion. White House officials remained steadfast, however, in supporting the Senate’s $1 trillion proposal, while some Senate Republicans have been opposed to any additional funding. In response to an inability to reach agreement, Senate Majority Leader Mitch McConnell (R-KY) then decided to recess the Senate after discussions collapsed on August 7. That legislative branch will not reconvene until September 8, but its members are prepared to return if the stalemate is overcome and a vote is scheduled.

The executive orders by President Trump include a payroll tax deferral for workers from September through December who make less than $100,000 a year, provision of weekly federal jobless benefits, expansion of a congressionally-approved eviction moratorium that expired in July 2020, relief for student borrowers, increased access to telehealth, support for rural hospitals, and the production of more drugs made in America while loosening federal drug-safety and environmental regulations that are perceived as placing domestic producers at a disadvantage. Perhaps the most controversial of these actions is the one involving the payroll tax deferral.

Democrats instantly expressed their disapproval by referring to where the “power of the purse” is vested. According to the U.S. Constitution. Article 1, Section 7, Clause 1: “All Bills for raising Revenue shall originate in the House of Representatives; but the Senate may propose or concur with amendments as on other Bills.” The Constitution also contains the following provision in Article 1, Section 9, Clause 7: “No Money shall be drawn from the Treasury, but in Consequence of Appropriations made by Law; and a regular Statement and Account of the Receipts and Expenditures of all public Money shall be published from time to time.” Some Republicans were not surprised at objections raised by Democrats, recalling that they also were upset when as part of the Affordable Care Act, President Barack Obama issued an executive order creating subsidies for insurance companies, thereby spending money that had not been appropriated by Congress as the power of the purse demands.

The full impact of these actions by President Trump has yet to be determined. Given the litigious nature of much that characterizes the relationship between Congress and the White House, a likelihood remains that this new set of differences between them will be referred to the courts for a resolution.

Return to July-August 2020 TRENDS

ANHEDONIA AND MORE PLEASURABLE TIMES

Kristen Truong

August 24, 2020

The term anhedonia could serve as the name of a mythical kingdom in a 1930’s movie about a place ruled by a madcap assortment of ardent Marxists (Groucho, Harpo, Chico, Gummo, and Zeppo). Instead, it denotes a clinical term to classify a condition that involves a diminished capacity to experience pleasure in acts that normally produce it. In his novel A Tale of Two Cities, Charles Dickens began the book with the following passage, “It was the best of times, it was the worst of times, it was the age of wisdom, it was the age of foolishness, it was the epoch of belief, it was the epoch of incredulity, it was the season of Light, it was the season of Darkness, it was the spring of hope, it was the winter of despair, we had everything before us, we had nothing before us (Dickens continued with additional contrasts, but the general thrust of his thinking seems evident).

The year 2020 began on a relatively positive note. The stock market was booming much to the benefit of retirement plans, unemployment was at all-time low levels, the upcoming college football series was on the near horizon, basketball’s March Madness was directly ahead, and students could look forward to colorful graduation ceremonies in late spring. Then, a malady known as COVID-19 entered the picture and hopes and dreams across the globe underwent a giant pause in fulfillment. Gloom and doom were accompanied by mass weeping, wailing, and gnashing of teeth as age-old darker thoughts regarding the loneliness of the soul and the human heart in conflict with itself began to resurface more forcefully.

The floodgates gradually opened and unparalleled amounts of information about this invisible intruder began to appear in mass media outlets, social media, and respected professional journals. Regarding the latter, an article published in the journal Science on May 29 of this year indicated that the COVID-19 literature had grown to more than 31,000 papers since January and by one estimate was on pace to reach more than 52,000 by mid-June. Reasonable queries seem justified, such as how is it humanly possible to stay abreast of the voluminous information being generated, and perhaps even more importantly, to what extent do all these articles meet acceptable standards associated with methodological rigor and the ability to draw accurate conclusions from the purported data?

Much research addresses broad categories involving vaccine development, treatment of patients, harmful impacts on health care personnel (e.g., PTSD and staff burnout), and incidence of community problems that pertain to domestic/child abuse, substance abuse disorders, and suicide. Widely heralded findings on remedial treatments, such as convalescent plasma and hydroxychloroquine, that are greeted with immediate approbation in some quarters soon are debunked by other investigators who insist that the results are uninterpretable due to non-randomized studies and lack of placebo controls. Meanwhile, excitement and enthusiasm precede the expected arrival of one or more vaccines to prevent the occurrence of infections. The following considerations remain pending: which population sub-groups should be vaccinated first, how long will protection be conferred, how safe is any new vaccine, and how effective will it be if the virus undergoes mutation?

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EFFECTIVE CORONAVIRUS MESSAGES FROM ACADEMIC INSTITUTIONS

Kristen Truong

June 26, 2020

Students and their families eagerly await messages from colleges and universities. The firm Eduventures conducts a Student Sentiment Survey annually to understand better how college-bound high school students research colleges and how they perceive institutional recruitment outreach. This year’s data include responses from 6,100 high school seniors, juniors, and sophomores across the nation. Respondents were asked whether they recalled a school that communicated particularly well during the crisis, and if so, what that communication entailed. Sixty-eight percent of seniors had positive experiences with institutional COVID-19 messaging . The top five communicators based on frequency and consistency of mention are listed in no particular order as follows:

Alvernia University
Prairie View A&M University
Southern Utah University
Oregon State University
University of Texas Rio Grande Valley

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TRANSHUMANISM AND THE PROSPECT OF NEVER HAVING TO DIE

Kristen Truong

June 26, 2020

Each passing day furnishes new evidence that the coronavirus has not yet fully completed its grim work of increasing the human ranks of the dearly departed. How refreshing then to come upon an article in the June 20-21, 2020 weekend edition of The Wall Street Journal that discusses optimistic views on the topic of transhumanism, the idea of using technology to overcome sickness and aging. Financial support for life-extension research has been provided by well-heeled investors as optimism abounds in some quarters that not only is it possible to live to the ripe age of 500, a time may arrive when individuals in middle age may have a fair chance of never dying. Starting with the premise that transhumanism promises that death can be conquered physically, not just spiritually, it appeared worth an effort to go to the professional literature to assess what progress is being made in achieving such lofty outcomes.

If an article appearing in May 2020 in the journal Clinical and Translational Science can be viewed as a reliably authoritative source for current thinking on such matters, then despite regenerative medicine (RM) being one of the hottest topics in biotechnology for the past three decades, it generally is acknowledged that the field’s performance at the bedside has been somewhat disappointing. RM is seen as having had an undeniable positive influence on the process of bench to bedside research. Preclinically, it has helped identify limitations of evidence‐based medicine and contributed to the paradigm shift to the trial‐and‐error method. If the translation of RM therapies is to be improved, however, many challenges to be overcome lie in the early stages of therapy development, such as identifying mechanism(s) of action, validating preclinical experimental models, and incentivizing translational research for basic scientists. Regulatory changes have been made in later stages, but much still needs to be addressed, such as adoption of clinical trials that are more rigorous and include long‐term follow‐up studies; development of appropriate manufacturing technology; synchronization of regulatory agencies, and a clear plan for reimbursement strategies.

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NIH FUNDING AND THE PURSUIT OF EDGE SCIENCE

Kristen Truong

June 26, 2020

With an annual budget of more than $37 billion, the National Institutes of Health (NIH) plays a critical role in funding scientific endeavors in biomedicine. Funding innovative science is an essential element of the NIH’s mission, but the ability to fulfill this aim has been questioned. Based on an analysis of a comprehensive corpus of published biomedical research articles (more than 24,000,000 of them in the MEDLINE database), a study was conducted to measure whether the NIH succeeds in funding work with novel ideas, referred to as “edge science.” The results are described in the June 2, 2020 issue of the journal Proceedings of the National Academy of Sciences of the USA. As background, it may be worth noting that both scientific and political considerations may lead the NIH to underfund trying out new ideas. First, because the NIH visibly spends public money, it needs to show discrete manifestations of improvements in health, as well as technological breakthroughs, arising from its supported research. This consideration can lead to a preference to support ideas that already have shown promise, rather than edge science. Second, NIH scientific review panels, for reasons related to their constitution, tend to reward projects that evidently are feasible over novel projects.

This investigation shows that edge science is more often NIH-funded than less novel science, but with a delay. Papers that build on more recent ideas are NIH-funded less often than are papers that build on ideas that have had a chance to mature for at least seven years. Three key findings are: First, the tendency to fund edge science is limited mostly to basic science. Papers that build on novel clinical ideas are not more often NIH-funded than are papers that build on well-established clinical knowledge. Second, novel papers tend to be NIH-funded more often because there are more NIH-funded papers in innovative areas of investigation, rather than because the NIH funds innovative papers within research areas. Third, the NIH’s tendency to have funded papers that build on the most recent advances has declined over time. In this regard, NIH funding has become more conservative despite initiatives to increase funding for innovative projects. Given the focus in this particular study on published papers, the findings reflect both the funding preferences of the NIH and the composition of the applications it receives.

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AVAILABLE RESOURCES ACCESSIBLE ELECTRONICALLY

Kristen Truong

June 26, 2020

Advancing Adolescent Flourishing: Moving Policy Upstream

A new report, Advancing Adolescent Flourishing: Moving Policy Upstream, on teen well-being in the U.S. finds that 60% of those ages 13-18 are not thriving, which is defined as experiencing positive emotions as well as positive emotional and social functioning. Teens also are reporting higher stress levels than older adults, the majority of which is due to mass shootings, concern about peers with anxiety and depression, and rising suicide rates. Majorities of teens also have been discriminated against, and almost all report hearing the word "gay" used disparagingly at school. The report identifies 47 action items that policymakers at local, state, and national levels can take to improve the well-being of teens. These items range from engaging with social media platforms and influencers to promote more content that encourages teens to spend time helping others in their community to encouraging lawmakers to design budgets with teenage well-being in mind. Enhanced teen-focused health policies at local, state, and federal levels of government will contribute greatly to the larger enterprise of healing the nation for all. Yet, current national investment in adolescents is lacking. The analysis includes action items and recommendations that are promising for advancing teen psychological, social, and emotional well-being. The report can be obtained here.

Preparing For The Next Pandemic

U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee Chairman Lamar Alexander (R-TN) released a White Paper, Preparing For The Next Pandemic, on June 9, 2020 that calls for public comment on five recommended areas for near-term congressional action to learn from the COVID-19 response and better prepare for future pandemics. He noted in an executive summary that “In the midst of responding to COVID-19, the United States Congress should take stock now of what parts of the local, state, and federal response worked, what could work better and how, and be prepared to pass legislation this year to better prepare for the next pandemic, which will surely come.” He outlined five main recommendations to improve the country’s preparation for future pandemics:

Accelerating research and development of tests, treatments, and vaccines.
Enhancing disease surveillance.
Addressing federal and state stockpiles, distribution, and surge capacity.
Improving state and local public health capabilities.
Improving coordination of federal agencies.

The White Paper can be obtained here.

New Data On Community Resilience

Community resilience is the capacity of individuals and households within a community to absorb, endure, and recover from the impacts of a disaster. The U.S. Census Bureau on June 22, 2020 released the Community Resilience Estimates to measure the ability of a population to be successful in responding to situations that include weather-related and disease-related hazard events such as COVID-19. Estimates are based on information on individuals and households from the 2018 American Community Survey (ACS), the Census Bureau’s Population Estimates Program, and National Health Interview Survey (NHIS) data. A tool showing risk level by state, county, and tract can be obtained here.

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QUICK STAT (SHORT, TIMELY, AND TOPICAL)

Kristen Truong

June 26, 2020

Prevalence Of Tooth Loss Among Older Adults, 2015-2018

A June 2020 Data Brief from the National Center for Health Statistics (NCHS) indicates that the prevalence of complete tooth loss among adults aged 65 and over was 12.9% and increased with age: 8.9% (ages 65– 69), 10.6% (ages 70–74), and 17.8% (ages 75 and over). Non-Hispanic black older adults (25.4%) had a higher prevalence of complete tooth loss than Hispanic (15.3%) and non-Hispanic white (10.9%) older adults. Prevalence of complete tooth loss was higher for older adults with less than a high school education (31.9%) compared with those with a high school education or greater (9.5%). From 1999–2000 through 2017–2018, the age-adjusted prevalence of complete tooth loss among all older adults declined significantly. Nevertheless, complete tooth loss can diminish quality of life by limiting food choices and impeding social interaction. Reducing this problem is a national health goal monitored by Healthy People.

Opioid-Involved Emergency Department Visits, Hospitalizations, And Deaths

A National Health Statistics Report on June 16, 2020 reveals that in the 2014 National Hospital Care Survey (NHCS), there were 15,495 patients with an opioid-involved ED-only visit and 24,059 patients with an opioid-involved hospitalization. Of the patients with an opioid-involved hospitalization, 1,805 died (9%) within one year of discharge. Of these deaths, 341 (19%) resulted from a drug overdose. Opioids most frequently mentioned included heroin (46%), fentanyl (20%), oxycodone (13%), methadone (12%), and morphine (12%). These categories are not mutually exclusive because a death may involve more than one drug. For approximately 22% of patients who died of an opioid-involved drug overdose in 2014, their last ED-only visit or hospitalization was opioid-involved. While lockdowns stemming from COVID-19 are aimed at preventing fatal infections, a concern is that social isolation may lead to increases in drug overdoses, suicides, and other health problems. Future studies will uncover the extent of such occurrences.

HEALTH TECHNOLOGY CORNER

Personalized Mapping Of Drug Metabolism By The Human Gut Microbiome

Previous studies have examined how single species of gut bacteria can metabolize oral medications, but a new framework enables the evaluation of an individual's entire intestinal microbial community at once. A research team at Princeton University used an approach to evaluate the gut microbiome's effect on hundreds of common medications already on the market by indicating how the microbial community in the intestines can chemically transform, or metabolize, oral medications in ways that have an impact on safety and efficacy. According to a study published on June 10, 2020 in the journal Cell, researchers identified 57 cases in which gut bacteria can alter existing oral medications. Eighty percent of those had not been previously reported, emphasizing the potential of the method for revealing unknown drug-microbiome interactions. The new methodology could aid the development of medications that are more effective, have fewer side effects, and are personalized to an individual's microbiome.

Magnetoelectric Materials For Miniature, Wireless Neural Stimulation At Therapeutic Frequencies

A major challenge for miniature bioelectronics is wireless power delivery deep inside the body. Electromagnetic or ultrasound waves suffer from absorption and impedance mismatches at biological interfaces. Magnetic fields do not suffer these losses, which has led to magnetically powered bioelectronic implants based on induction or magnetothermal effects. These approaches have yet to produce, however, a miniature stimulator that operates at clinically relevant high frequencies. A manuscript published on June 8, 2020 in the journal Neuron describes study results suggesting that using magnetoelectric materials for wireless power delivery is more than a novel idea. These materials are viewed as being excellent candidates for clinical-grade, wireless bioelectronics. Tiny implants capable of modulating activity of the brain and nervous system could have wide-ranging implications and could be useful for treating depression, obsessive-compulsive disorders and more than a third of patients who suffer from chronic, intractable pain that often leads to anxiety, depression and opioid addiction.

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DEVELOPMENTS IN HIGHER EDUCATION

Kristen Truong

June 26, 2020

As summer moves forward, administrators of academic institutions at all levels continue to be plagued by doubts and uncertainties regarding whether schools should be reopened and students readmitted in coming months. When infections occur, youth cohorts have not been affected as drastically by COVID-19 in comparison to adult groups, especially patients 80 years of age and older. Nonetheless, once infected, even if asymptomatically, students have the potential to transmit this deadly disease to adults with whom they come in contact, such as teachers, and older relatives. A significant unknown is the extent to which parents are willing to have their offspring attend school as long as there is a perceived threat of infection.

What Will The College Football Season Look Like This Year?

Many colleges, and even high schools, depend on financial support derived from athletics. College football is a bountiful source of revenue as evidenced by stadiums that seat more than 100,000 fans who not only buy tickets, but even spend generously on concessions. Enlightened officials at some institutions have seen the value of adding alcoholic beverages to what is sold to patrons as a means of enhancing the amount of money flowing into school coffers. Players already are in training on some campuses and reports indicate that some of them are testing positive for the coronavirus. Although many are in superb physical condition, it is not uncommon for offensive and defensive linemen who weigh more than 300 pounds to be classified officially as being obese, a condition that has contributed to mortality outcomes among other segments of the population with this condition who became infected. Given the airborne capability of the coronavirus to be transmitted over a considerable distance by screaming fans at these events, a challenge is presented in figuring out how to adjust social distancing patterns safely in arenas. Fewer seats that are filled also can exert a negative impact on revenues.

Institutions Are Unequal In their Ability To Withstand Revenue Shortfalls

Apart from any health dangers posed by the presence of the appearance of a deadly infectious disease on school grounds, there can be severe financial consequences for failing to reopen some academic institutions. Publicly-funded schools are somewhat shielded from hazards associated with reductions in tuition income and student fee revenues, but the same cannot be said of their counterparts in the private realm. Prior to the appearance of the coronavirus, many states already were reeling financially because of increased pressures arising from growing expenditures in their Medicaid programs. As job losses began occurring on a massive scale in the U.S. beginning in March of this year, that economic contraction typically was accompanied by cancellations of health insurance coverage that is connected to employment status. Individuals so affected by losing their health insurance now have to rely on Medicaid coverage, which adds to the financial woes of many states that will find it increasingly difficult to devote resources to an ailing educational sector. Moreover, a related concern is that revenue obtained through fund raising and philanthropic contributions may not be as robust as it has been previously.

Rethinking Accreditation And Quality Assurance

The past several years have been characterized by a shared sense that current quality review needs to be reimagined to serve students and society more effectively. Judith Eaton, President of the Council for Higher Education Accreditation (CHEA), expressed her thoughts on this matter in June 2020 by identifying five specific steps that can lead to reinventing a review of quality in higher education, a post-Covid redesign of accreditation and quality assurance that, if effective, will establish a foundation for the next era of these important efforts. Accreditation and quality assurance are needed that capture quality, while embracing new providers and creatively using technology that brings students greater opportunity, access, and progress in furthering their education. The five steps are:

Sustain the fundamental value commitments of higher education
Expand the range of activity and scrutiny of quality review
Modify the primary purposes of accreditation and quality assurance
Enlarge the universe of accreditation/quality assurance providers themselves
Redesign the accreditation/quality assurance review process

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HEALTH REFORM DEVELOPMENTS

Kristen Truong

June 26, 2020

The appearance of COVID-19 in the United States has had a major impact on the nation’s health care delivery system. Lockdowns in many states are viewed as being successful in slowing down the rate at which new cases of the disease occur. Now that such restrictions have been loosened, in many jurisdictions there is a resurgence in the number of new cases as businesses reopen and some individuals choose to refrain from wearing masks when in public settings. The number of hospital admissions continues to grow in certain states, heightening a concern that the ability to treat newly infected patients may be compromised if hospital facilities become sufficiently overwhelmed.

Older Americans are disproportionately affected by this disease. Data released by the Centers for Medicare & Medicaid Services (CMS) on June 22, 2020 show that that more than 325,000 Medicare beneficiaries had a diagnosis of COVID-19 between January 1 and May 16 of this year, which translates to 518 COVID-19 cases per 100,000 beneficiaries. The data also indicate that nearly 110,000 beneficiaries were hospitalized for COVID-19-related treatment, which equals 175 COVID-19 hospitalizations per 100,000 beneficiaries. Blacks were hospitalized with COVID-19 at a rate nearly four times higher than whites. Disparities go beyond race/ethnicity and suggest the impact of social determinants of health, particularly socio-economic status. End-stage renal disease (ESRD) patients (individuals with chronic kidney disease undergoing dialysis) had the highest rate of hospitalization among all Medicare beneficiaries, with 1,341 hospitalizations per 100,000 beneficiaries. These patients also are more likely to have chronic comorbidities associated with increased COVID-19 complications and hospitalization, such as diabetes and heart failure.

Medicare And The Health Care Delivery System

The Medicare Payment Advisory Commission’s June 2020 Report to the Congress: Medicare and the Health Care Delivery System was issued on June 15, 2020. The Commission believes that unless substantial changes are made to the way Medicare pays for services and to how beneficiary care is organized and delivered, the cost of the Medicare program will remain on an unsustainable trajectory. The Part A trust fund is projected to exhaust its reserves in 2026, which will force Medicare to reduce payment rates sharply for hospitals and other Part A providers unless policymakers take some other action. The Commission asserts that the use of fee-for-service payment for Medicare services should be replaced, over time and to the degree feasible, by payment to accountable systems of care that have incentives to: provide preventive services and early disease detection, improve the quality and beneficiary experience of care; avoid delivering unnecessary or inappropriate services; control the costs of providing necessary services in the most appropriate care setting; deliver chronic care services through care coordination among providers; coordinate both the medical and nonmedical needs of beneficiaries; and enhance the use of technologies that improve quality and reduce program costs. Moreover, serious attention must be given to new innovations, for example, changing how hospitals are paid and giving providers incentives to manage the cost of medications.

Report To Congress On Medicaid And CHIP

The Medicaid program was instrumental in providing coverage to the uninsured when the Patient Protection and Affordable Care Act became law in 2010. Medicaid is playing this same role during the COVID-19 pandemic. Unemployment that results in loss of health insurance coverage through one’s job has helped to fuel a surge in the rolls of Medicaid beneficiaries. The Medicaid and CHIP Payment and Access Commission (MACPAC) on June 15, 2020 submitted its June 2020 Report to Congress on Medicaid and CHIP. This document contains six chapters addressing three fundamental challenges facing Medicaid: (1) improving integration of care for low-income seniors and individuals with disabilities who are dually eligible for Medicaid and Medicare; (2) ensuring that Medicaid is the payer of last resort when beneficiaries also have coverage from another insurance program; and (3) addressing concerns about high rates of maternal morbidity and mortality. A focus is on integrating Medicaid and Medicare, two separate programs that were not designed to work together, for beneficiaries who are eligible for both entities. Dually eligible beneficiaries account for a disproportionate share of Medicaid and Medicare service use and spending. Integrating the delivery and financing of their care is viewed as having a potential to address better the totality of their needs and reduce spending.

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CONGRESS IN A TIME OF CORONAVIRUS

Kristen Truong

June 26, 2020

A presidential election year can produce distortions in how Congress normally functions. The party in control of the White House typically stands to benefit in an election year from the passage of legislation that is popular with the electorate. Developments of that nature furnish a rationale for proclaiming why it is imperative that the political party in power remain in that position to ensure that good times continue to roll forward. The opposition party views the situation quite differently, finding it more convenient to prevent the passage of progressive legislation. That stance enables them to point an accusative finger at incumbents as being ineffective in accomplishing what is necessary. Their rationale is that it is high time for positive changes to occur and they inform the electorate in loud and clear terms that they are the political party with the ability to achieve desirable outcomes.

The year 2020 is proving to be vastly different. A main reason is that COVID-19 persists in being a major concern as of the end of June. As lockdowns have been loosened around the U.S., new cases of this disease continue to appear and hospitalizations are on the rise. Additional remedies are sought and can be implemented, but it is patently clear that agreements of a bipartisan nature are required. A recent example of a willingness to work cooperatively is a letter by a bipartisan group of 30 U.S. senators that was sent on June 15 to Majority Leader Mitch McConnell (R-KY) and Minority Leader Charles Schumer (D-NY), asking them to make permanent certain provisions from the bipartisan CONNECT for Health Act that were included in previous COVID-19 legislation. These provisions led to an important expansion of access to telehealth services for Medicare beneficiaries during the pandemic.

The reason for advocating increased access to telehealth stems from its potential to expand availability of health care, reduce costs, and improve health outcomes. Telehealth has proven to be pivotal for many patients during the current pandemic, ensuring that they receive the care they need while reducing the risk of infection and the further spread of COVID-19. Expanded Medicare coverage of telehealth services on a permanent basis, where clinically appropriate and with appropriate guardrails and beneficiary protections in place, would ensure that telehealth continues to be an option for all Medicare beneficiaries after the pandemic ends.

Supporters of this initiative believe that the population has benefited significantly from this expansion of telehealth and have come to rely on its availability. They stress that Congress should expand access to telehealth services on a permanent basis so that telehealth remains an option for all Medicare beneficiaries both now and after the pandemic. Doing so would assure patients that their care will not be interrupted when the pandemic ends. It also would provide certainty to health care providers that the costs to prepare for and use telehealth would be a sound long-term investment.

Apart from telehealth, other major decisions are pending on the near horizon. One of them has to do with deciding if a federal supplemental unemployment benefit of $600 per month should be extended beyond July 31 when it is scheduled to end. From a health professions workforce standpoint, S. 3993 is a bill introduced in the Senate on June 17 to permit a licensed health care provider to offer health care services to individuals in one or more States in which the provider is not licensed.

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PRESIDENT’S CORNER

Kristen Truong

June 25, 2020

Leadership During Change

Higher education is in the midst of transformational change due to the pandemic. It has been experiencing pressures to change for some time now. The pandemic has just accelerated and significantly disrupted any sense of tradition activity. Leaders have had to react and recover, and now must reinvent their future as the political, economic, social and cultural ramifications of this disruption become known. Universities are forming partnerships, restructuring campus units, consolidating programs, and elevating the importance of their teaching and learning center and IT departments to adapt to new ways of learning.

Whether you are a program director, department chair, or dean, the recent confluence of events is testing your leadership like never before. Common advice for leaders during this time is to first and foremost make health and safety the top priority for everyone. Engaging parties from all units on campus in strategic planning should include staying true to your mission, protecting the health and safety of students and employees, and adopting flexibility, creativity and adaptability as means of preserving your future.

Leaders can help their teams with transition by working with campus administration to clarify the vision and establish structures that support change. It is important to keep the whole college and campus in mind when making changes as actions taken in one program or department can affect the entire college and campus. Feedback on proposed changes should come from both inside and outside of the university to reach various stakeholders and receive diverse perspectives from which to make better informed decisions.

In order to get the support of those affected by change, the rationale or purpose of the change must be clearly conveyed. Clear, open, authentic and consistent communication is key to earning support for change from others. This can be done through multiple channels including email, teleconferencing, newsletters, etc. Encouraging questions and feedback indicates a leader’s receptiveness to listening and understanding others’ viewpoints.

Modeling a positive response to organizational change and conveying trust in campus leadership can also provide additional assurance to your team that change is being handled with competence. For more insights on leadership during change, I encourage you to use your ASAHP membership network, attend ASAHP’s ongoing webinars, join ASAHP’s online communities, and watch for a series of upcoming virtual presentations on current topics.

“Be the Change You Want to See in the World” ...... Mahatma Gandhi

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COVID-19 VACCINE CLINICAL TRIAL CONCERNS

Kristen Truong

June 25, 2020

Announcements have been made that Moderna, the University of Oxford and AstraZeneca, and Johnson & Johnson independently of one another will begin testing proposed coronavirus vaccines in stage three trials beginning in July 2020. Related to the important matter of whether these attempts or any related investigations will yield products that protect against the onset of COVID-19 is the essential question of which kinds of individuals will benefit from this research. Key demographic characteristics, such as age, gender, and race/ethnicity help to distinguish one person from another. Unless the pool of participants in these clinical trials adequately reflects such differences, then the overall impact of any vaccine may be limited to representatives of groups taking part in such studies.

Major shortcomings presently exist in the composition of participants in clinical trials. As reported in the March 2020 issue of the journal Contemporary Clinical Trials Communications, adult participation in U.S. cancer clinical trials is at less than 10% of cancer patients, with even lower rates for racial and ethnic minority groups. For example, African Americans comprise 5% of patients enrolled in trials that support FDA approval of new drugs, while representing 13.3% of the general U.S. population. Cancer is the leading cause of death for Asian Americans, yet they comprise just 3% of cancer participants in clinical trials. Also, Hispanics represent less than 3% of participants in similar investigations, despite accounting for an estimated 17.8% of the U.S. population.

An under-representation of older adults in cancer clinical trials remains an ongoing concern. Consequently, optimal treatment in this group remains undefined. The January 2020 issue of the Journal of Geriatric Oncology describes challenges involving efforts to increase their level of participation. Older adult cancer patients, differ from younger adults since they often possess more comorbidities, take more medications, and have diminishing organ function, which often excludes them from clinical investigations. Furthermore, older adults enrolled in studies tend to be fitter and healthier than the average older patient seen in clinics, which leads to uncertainty about the risks, benefits, and tolerability of systemic therapies in the older population.

Potential barriers to enrollment of older adults in trials have been identified. One reason for non-accrual of older adults is due to trial unavailability or patient ineligibility. Strict exclusion criteria, especially those related to functional status, organ function, and comorbidities, which are common in older patients, can serve as major enrollment barriers.

Mortality data for victims of the COVID-19 epidemic show that some portions of the U.S. population have been devastated more than other demographic segments. Patients 80 years of age and older residing in long-term care facilities have been particularly hard hit. African American males also have died at significantly higher rates than their proportion of the population would suggest. Thus, it would be most prudent to ensure that stage three vaccine trials represent these groups adequately.

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More September 2020 TRENDS Articles

A QUASI-CATEGORICAL DEMURRAL