Washington University ENT expands to serve North St. Louis County

Washington University Otolaryngology has expanded once again and will now see patients at Christian Hospital Northeast Medical Building in North St. Louis County.

As of Nov. 1, the clinic space is fully owned by WashU ENT. The practice had been renting the space from BJC Medical Group since March 1.

Christian Hospital is a full service acute-care medical center, noted for its excellence in heart services and cardiothoracic surgery, emergency medicine, breast health services, orthopedic/spine surgery, vascular surgery, endocrinology, radiology, urology, wound care, and pulmonary care. Siteman Cancer Center at Christian Hospital began seeing patients in July 2017. WashU ENT hopes to build on those accolades with world-class otolaryngology care.

Most of our specialties are still in a growing phase, according to head and neck cancer specialist Jose Zevallos, MD.

“I mostly do endocrine surgeries at Christian Hospital right now,” he said. “That will expand as the hospital becomes equipped to handle more complex head and neck surgery.”

“Patients want to stay within their communities for care, and the continuity and depth of care that WashU offers is a real benefit to these patients.”Gerald Moritz, MD

WashU ENT specialists currently seeing patients at Christian Hospital include Zevallos, neurotologist Nedim Durakovic, MD, comprehensive otolaryngologist Gerald Moritz, MD, and sinus and skull base surgeons John Schneider, MD, and Nyssa Farrell, MD. All have clinical commitments at the facility that vary from one-half day to four days per week. They have blocked operating room time for surgical procedures in addition to their clinic commitments.

Dr. Farrell treats a variety of sinus conditions requiring procedures of the nose and paranasal sinuses, endoscopic sinus surgery, nasal obstruction, nosebleeds, and nasal tumors.

“Our presence means increased access to care for ENT problems in patients in northern St. Louis,” she said. “We are privileged to be able to provide that care.”

Dr. Moritz has had a private ENT practice at Christian Hospital since 1975. Now, as a WashU faculty member, he sees ENT patients at the new clinic four days a week.

“The hospital has had a strong ENT presence in the past, including an active head and neck cancer program,” he said. “Maintaining a program like that is difficult to do in private practice, so those patients were often sent to St. Louis University Hospital.”

Moritz’s practice joined the BJC Medical Group eight years ago, and he says the real benefit to being associated with an academic medical center is in the treatment of complex cases like head and neck cancer.

“The presence of WashU ENT at Christian Hospital offers a real advantage to North County residents,” he said. “Patients want to stay within their communities for care, and the continuity and depth of care that WashU offers is a real benefit to these patients.”

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ENT researcher works to optimize benefits of cochlear implants in children

Lisa Davidson, Ph.D., and her lab are determined to help optimize the benefits of cochlear implants (CIs) and hearing aids (HAs) to maximize spoken language and literacy development in children with hearing loss. Davidson’s teammates include Rosalie Uchanski, Ph.D., assistant professor of otolaryngology, Sarah Pourchot, and Christine Brenner.

“Long-term verbal abilities and ultimately academic success depend on making the right device decisions at the youngest age possible,” said Davidson. Her lab seeks to establish empirically driven guidelines for determining the best hearing-device combination (one CI and one HA or two CI) for pediatric patients during their critical language-development years of birth to four years of age.

For young children with severe-to-profound HL, clinicians now unanimously agree that two ears/two devices are better than one ear/one device. For some children, early receipt of two CIs provides them the best opportunity to develop good spoken language skills, helping them to identify and produce the phonetic elements of speech.

For other children, the use of a CI with a HA at the non-implanted ear may be the best option.  AHA transmits unique acoustic properties of speech not available through CIs, such as voice and emotion recognition and phrase boundary and intonation cues that facilitate early language learning.

In spite of this, few research studies have examined which children would benefit from early acoustic input from a HA along with a CI for some period of time. As CI is increasingly considered for children with more residual hearing, a careful examination of the evidence for recommending this two-device option is crucial.

Based on a recent NIH-funded longitudinal study of 117 children, from across the USA, aged 5-8 years with either 2CIs or CI+HA, the Davidson lab identified ranges of residual hearing levels that can guide clinicians in making two-device recommendations for individual pediatric patients.

“In general, we found that children with hearing levels better than approximately 90 dB HL are likely to have better-spoken language and reading skills when CI+HA devices are used in the first [approximately] four years of life than when two CIs are used in these early years,” said Davidson.

Davidson’s current study focuses on the long-term consequences of these early device decisions. During early elementary grades, most children with CIs move from classrooms specialized for those with impaired hearing to general education classrooms. Compared to specialized classrooms, general classrooms have more occupants, more noise, and more visual distractions.

Yet, it is in these classrooms where children with CIs must acquire complex language, communication and literacy skills. They must learn to use vision to supplement auditory input, making audiovisual speech perception and binaural listening skills critical to their academic, communication, and social functioning says Davidson.

“For our current NIH-funded project, we are evaluating these skills in the same children tested in the previous study who have now reached early adolescence,” said Davidson. “The follow-up assessment battery examines whether the early acoustic experience via a hearing aid contributes to, or detracts from, their audiovisual and binaural listening skills which are implicit in ’real world’ communication and socialization.”

To test the children in this large-sample longitudinal study, Davidson’s research team had been traveling to schools for the deaf and to CI clinics across the country.  Currently, COVID-19 has prevented the lab team from conducting on-site, in-person tests. During this period of restricted travel and restricted in-person meetings, the lab team has been administering standardized spoken language tests (CASL-2) and quality-of-life questionnaires remotely.  They are also working on converting other portions of their test battery to an online format. Once travel can be resumed, these efforts should help minimize the amount of time spent doing on-site testing.

The Davidson lab collaborates with colleagues here at Washington University and other sites to examine the effects of cochlear implants and hearing aids on various outcomes measures including literacy, hearing quality of life, binaural processing, and audiovisual perception. Collaborators include Jill Firszt, Ph.D., Ann Geers, Ph.D., Heather Grantham, Ph.D., Judith Lieu, MD, and Brent Spehar, Ph.D.
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Head and neck division sees development of endocrine specialty

Jose Zevallos, MD, division chief of Head and Neck Surgery in the Department of Otolaryngology at Washington University has developed a new niche in his head and neck practice –  endocrine surgery. He is now among the busiest thyroid and parathyroid surgeons in the region, doing several cases each week between Barnes-Jewish Hospital and Christian Hospital Northeast. He finds the surgery both rewarding and challenging.

Jose Zevallos, MD, MPH

“While these surgeries are commonly done, improved outcomes are associated with high-volume surgeons,” he said. “A significant part of my practice focuses on second opinions, advanced cancers, and repeat surgeries in patients who previously had incomplete resections or develop thyroid cancer recurrence.”

Many patients who get thyroid and parathyroid surgery are otherwise very healthy and tend to be young. Quality of life and excellent surgical outcomes are very important.  The nerves that move the vocal cords and help give your voice pitch and tone need to be identified and kept safe during surgery. Zevallos agreed this is probably his most important concern as the surgeon.

Surgery involves the removal of all or part of the thyroid gland or one or more parathyroid glands. These procedures can impact hormones produced by these glands for distribution throughout the body.

A model of the anterior neck to show the location of the thyroid gland (orange structure, number 13) at the front of the neck just below Adam’s apple (#10).

“Working closely with endocrinology in deciding candidacy for surgery is another very rewarding part of my role,” said Dr. Zevallos.  “Not every patient with a thyroid nodule needs a biopsy or surgery, and making multidisciplinary decisions along the way ensures the best outcomes for our patients.”

The thyroid gland is a small organ that’s located in the front of the neck, wrapped around the windpipe (trachea). It’s shaped like a butterfly, smaller in the middle with two wide wings that extend around the side of your throat.

Your thyroid creates and produces hormones that play a role in many different body systems. When your thyroid makes either too much or too little of these important hormones, it’s called a thyroid disease. There are several different types of thyroid disease, including hyperthyroidism, hypothyroidism, thyroiditis, and Hashimoto’s thyroiditis.

A posterior view of the larynx in this model reveals the small parathyroid glands (arrows) embedded in the thyroid gland.

The thyroid is one of a number of endocrine glands that produce hormones to control the activity levels of many organ systems. Thyroid hormones like T3 and T4 tell the body’s tissues how much energy to use, to keep metabolism at an appropriate level. It also produces calcitonin which helps regulate calcium levels in the blood.

The parathyroid disease affects the parathyroid glands, four pea-sized bodies embedded in the posterior part of the thyroid gland. These glands produce parathyroid hormone (PTH), which helps maintain the correct levels of calcium in the body by opposing the action of calcitonin. Normally, the glands release just enough PTH to keep calcium levels normal. Disease states like hyper- and hypoparathyroidism and parathyroid cancer can disrupt this delicate balance.

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COVID-19 shows the world needs physicians who can look beyond medical charts

As modern medicine has advanced, so too has our understanding of what affects health. Over recent decades this has generated a number of new fields in medicine. One of the most important that has been born out of the latest generation is social medicine. It studies how social and economic factors help determine our health, specifically inequalities within societies that negatively influence health outcomes.

Similar to primary health care, social medicine prioritizes health equity and promotes a broad view of health, multi-sectoral action, and the participation of communities. Both significantly contribute to progress in improving health equity.

COVID-19 has placed a spotlight on the field of social medicine. It has done so by showing up inherent injustices in society. An example is a fact that African-American and Native American communities in the US are experiencing disproportionate COVID-19 deaths. The result is that more people are beginning to argue that social medicine should take center state in the medical community. But the argument towards a more progressive approach to healthcare is also being met with criticism by those who still cling to the traditional model of medicine.

The argument has come to head over approaches to medical education.

The main argument against a ‘social medicine’ orientation in medical education is that it comes at the expense of “practical preparation” in areas like pandemic response and disaster preparedness. In a recent article a professor of medicine, Stanley Goldfarb, went as far as to argue that social medicine should be removed from “the traditional American model of medical training.”

We are firmly in the camp of those who believe that social medicine is an integral part of the formation of health care professionals. We strongly believe that our trainees and graduates need to be content experts and “practitioners”. But that they also need to understand the social determinants of health and diseases.

Both are necessary for an integral understanding of any major health challenges – including pandemics.

Our view is that it’s not a question of social medicine at the expense of emergency medicine. This is a false dichotomy. Increasingly research has shown that a multi-sectoral approach is needed to deliver effective healthcare. Clinicians should understand how factors such as poverty, food insecurity, and racism have an impact on the population’s health. This is particularly true for the most vulnerable.

Consider this example: it’s not uncommon in many developing countries to see a malnourished child get admitted to a hospital with serious complications. They receive appropriate care – including food – recover significantly and are discharged in a very good state. But they are then readmitted with the same condition.

The “treatment” of this child is not only the hospital-based administration of the food and medicine. It goes far beyond to food security, safe water provision, environmental health, and other determinants of health and disease.

Both lenses are needed

Doctors should be trained in emergency and critical care. They should also be trained in social medicine. Missing out on either renders responses inadequate.

One danger of a one-track approach to medical education is that it creates technically capable physicians who are dangerously unaware of the numerous factors that determine health on the individual, community, and global level.

This makes them ill-prepared for the reality of clinical experience.

The reality is that an application of both social justice and a bio-social lens, which focuses on how social factors influence health, are needed to understand how different groups are uniquely affected by an event such as the current pandemic, how they access existing health services, and how this, in turn, can affect a nation’s pandemic preparedness and response.

For example, in the US the coronavirus is disproportionately affecting African Americans. In US hotspot Louisiana, more than 70% of COVID-related deaths have been among black Americans, despite making up only 33% of the population, according to the Louisiana Department of Health.

Health professionals need to understand why. One reason could be the well-documented mistrust of the US health sector, which has, in the past, compromised public health responses. This has been also documented in other parts of the world, such as during outbreaks of tuberculosis, preventing the spread of HIV in Africa, and efforts to contain Ebola outbreaks.

Why social justice matters

The experience of COVID-19 has been a case study in why medical students need exposure to more, not less, social justice issues.

There is a reason why medical schools globally are adopting these principles of social medicine, and why students encounter patients before they graduate.

It comes back to the problem that has plagued the success of multiple health policies over time; how can you design and implement health systems, or treat patients, without understanding the historical, social, geographic, and political circumstances of those you are serving?

An effective pandemic response can’t be separated from the how or the why of its arrival, the factors contributing to its transmission, or its devastating after-effects.

Concentrating only on fundamental classroom training puts a metaphorical plaster on the wound, and simply awaits the next graze on the knee. Understanding how and why these diseases come to fruition avoids taking these learnings into the future and protects millions of lives.

Putting patients at risk

From our experience as health practitioners and health educators, medical education that is not patient-centered and pinned around social medicine puts patients at risk.

Of course, the world needs physicians “who are better prepared to help battle deadly pandemic diseases like COVID-19”. But students also need enough bio-social tools and social justice training to prevent, respond and disaggregate the burden of pandemics in a way that’s inclusive of everyone. And consequently, benefit entire societies.

Not doing this increases the risk for all – even those who have the privilege of accessing care.

Only by training a new generation of physicians who can look beyond medical charts and see the bigger picture can we be prepared for the next pandemic – and any other health challenge we will face in the future.

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Flight Shift

Emergency medicine lessons learned in the cockpit of an F-15c

It’s a familiar story: after getting selected and working through thousands of hours of lectures, training, and evaluations, I was told I was ready. Yet, after all, that, when I heard the first code of my career, my mind went blank, my heart took off, anxiety took over and I was left scared and overwhelmed.

That was the second time in my life I felt exactly that way. The first time, I had just completed my final checkride in the F-15C with my Squadron Commander. After several years of training, I was finally a “Combat Mission Ready” F-15C pilot. That final checkride was on September 10, 2001. The next day I was prepping F-15C’s armed to the teeth with live weapons, and I was scared and overwhelmed.

As both a brand new fighter pilot and a new physician I was just barely safe, but there was a difference in how I coped with the stress. Inherent in the training of a combat pilot are cognitive tools and lessons taught to keep pilots alive and carrying out their missions under the most extreme situations. We used to say that these lessons were written in blood. As resuscitationists, we can learn from combat pilots and apply these same cognitive tools in the ED.

Imagine this: you are a combat pilot flying across the line. You are at 30,000 feet leading an 8-ship of F-15Cs (air-to-air fighters) protecting a strike package of some 30 other jets and assets. The radio calls are nonstop, your radar looks like a Christmas tree, you’re getting “spiked”, you have a minor hydraulics problem, the formation is getting sloppy, the strike package is not where it should be, and now radar control calls a new hostile group of your nose. You’ve got what pilots call a “helmet fre” – you’ve momentarily lost situational awareness because of stress and task saturation. But you know how to deal with it because of your training.

This is not unlike a nightmare scenario in the resuscitation bay. Imagine you have a crashing 55-year-old GI bleeder. The ED is packed. The nurses are having a hard time getting IV access. The patient is getting somnolent. Everyone is well intentioned but completely disorganized. You haven’t intubated someone this sick in years. Your mind is running in circles. You’re embarrassed to ask for help or reference any resources. You fixate on his O2 sats going down. There is a vacuum of leadership because you are so task-saturated you can’t co-ordinate your team. You too have a “helmet fire”. How do you deal with it? Has your training formally prepared you?

In high-stress situations, the combat pilot focuses first on himself and his jet, then moves out to the team, and then the organization. A resuscitationist can do the same. Here are specific concepts from combat aviation that you can use in your EDs tomorrow:

Self: The Boldface

An aviation concept introduced on day one of pilot training is that of “The Boldface”. These are very succinct corrective procedures that address those few emergencies or tactical situations in which you have to do something right now or people will die. There are only a few of these for each jet. In the F-15 there were maybe six. Things like an engine fire, spin recovery, ejection… the “no shitters” as we called them. “The Boldface” is designed so that when you are incredibly overwhelmed, task saturated, and time is short, you can still function and survive. These procedures are absolutely committed to memory such that you know them verbatim at any given time.

We don’t really have this concept in emergency medicine. But we could since only a few emergencies really need to be treated within seconds. Pulseless VFib/ VTach comes to mind. The Boldface would read, “Shock, start CPR”. After the Boldface is completed, use your resources and checklists. Checklists liberate our minds to do “doctor things” and not get caught in the weeds. It is unconscionable that it is considered “weak” or “not cool” to use resources like this that can save lives. The hubris required to think that we as doctors don’t need backup like this is just unforgivable. Jet Jocks aren’t too cool to use them, so why are we?

Self: Crosscheck

The basic aviation concept here is to never fixate on any one instrument or parameter. In a tactical situation, if you fixate on any one instrument – the radar, your tactical display, your “spike status”, the radios – you will miss critical information and someone will die. Likewise, in a resuscitation, we cannot fixate on any one instrument or vital sign. We’ve all seen the situation where everyone is hypnotized by a positive FAST while the patient is bleeding out, or there is a bad open tib-fib fracture that everyone zeros in on while the patient is apneic.

Translating this aviation concept to medicine, we need to take a position of leadership, likely at the foot of the bed and start our medical crosscheck. Mine revolves around the patient and goes something like a patient – O2 sats – patient – nursing – patient – BP – patient – medics – patient – ultrasound, etc.. This crosscheck will help us see the global picture and set appropriate priorities.

Self: Task Prioritization

A core aviation mantra is “Aviate–Navigate –Communicate”. This is always the order you do things in the jet. I have studied multiple jet mishaps where this was the root cause of an airplane turning into a smoking hole. In fact, one time while flying the F-15C, I was so task saturated by looking at my radar and listening to the tactical comm that I found myself at 90 degrees of bank, 30 degrees nose low, and 550 knots at 1000 feet above the ocean which looked just like the sky. I was navigating and communicating, but I wasn’t aviating. I had 5-10 seconds to live when the Hand of God lifted my eyes out of that cockpit and got me aviating again.

Now, I think this concept can especially help our residents with attention prioritization in a resuscitation. The medical spin on this concept would be “Resuscitate (ABCs)–Differentiate–Communicate”.

Resuscitate (ABCs): Accomplish the boldface and secure the most immediate ABCs Differentiate: Figure out where we’re going via our differential, then bring order to chaos

Communicate: With our team as the team leader

Team: Communication

Efficiency in communication during a dogfight is imperative. If a bandit rolled up behind my wingman I would call, “EAGLE 2, BRAKE RIGHT, FLARE! Bandit, your 6 o’clock high 1 mile”. Communication follows a hierarchy. It is directive, then descriptive, then informative.

Now, how can we use this in a resuscitation? We’ve all seen resuscitations go horribly because the lead physician doesn’t step up. There is a vacuum of leadership and communication. That vacuum can only be filled by us. It is why we trained and why we are there. It is what the team needs and wants. Our leadership brings order to chaos.

So we must be directive, descriptive and informative. Directive: Talk to someone specifically and give directions. “Resident Smith, place a central line.” Descriptive: “in the right femoral vein.” Informative: “we’re having problems getting IV access and the patient is bleeding out.”

In one sentence, a specific team member knows exactly what is expected of them and why. Clear unambiguous communication is your leadership in action.

Team: Briefing

The idea with a pre-flight briefing is to plan your sortie. The Flight Lead establishes a singular mission, defines roles, and sets the tone. The saying was that if it was a good briefing, it would be a good mission. These briefings typically took about an hour.

Now, an hour of pre-brief is clearly not possible in a resuscitation. But this concept can easily be applied to us. A 20-second briefing, even if the patient is already in front of us, is wildly valuable. This is as simple as stating what is known about the patient. This does a couple things: it establishes that someone is leading the resuscitation, it gets everyone on the same page, and it starts 2-way communication with your team as they add info that you don’t know.

We’ll discuss the debrief at another time, but the bottom line is that “learning and team building happens in the debrief.”

Organization: Read Files

This is probably the easiest concept, but one that I have yet to see in any ED. In the flying world there are many moving parts with changes occurring hourly. Some examples are: a local taxiway is out, there are new ordinance arming procedures or the departure procedure has changed. All of these items are very important and impact your sortie. The Pre-Flight Read Files consolidate this information in a simple, easily referenced binder. Pilots are simply not allowed to fly until they’ve read and signed of the current Read Files. This rarely takes more than a few minutes to accomplish. Simple.

Now, how many times are you on shift, trying to do your job, and after a delay you randomly find out that there’s a new procedure for admitting to the Peds ICU, or the hospital is out of Propofol, or Psych now needs LFTs, D-dimers, and head CTs on every admission?

A Pre-Shift Read File in one centralized binder that takes no more than a minute to read before every shift solves this problem. It standardizes procedures, increases global situational awareness, and sets us up for success on our shift. Email is not acceptable, nor are messy bulletin boards from the 1980s. This is a simple solution to keeping us current on what’s going on in the ED and the hospital.

So let’s apply these concepts to the 55-year-old GI Bleeder from earlier…

“The Boldface” dictates immediate actions for the most critical emergencies:

You are the resuscitationist, you bring order to chaos, you quickly assess this patient and note that right now there is no Boldface to accomplish, you take a position of leadership at the foot of the bed.

“The Crosscheck” keeps our situational awareness high. You start your crosscheck patient-monitors-patient-medic-patient-airway equipment..

“Resuscitate (ABCs) – Differentiate – Communicate” mantra directs focus and prioritization. You need to get IV access, secure the airway, and start blood. At the top of your differential are esophageal varices and peptic ulcers.

“Briefing” gives the team a vector. You give a 20-second briefing to organize your team, spell out your immediate thought process, and get everyone on the same page. “OK, we have a sick 55-year-old GI bleeder who is pale, hypotensive, tachycardic and becoming somnolent. Lets plan on intubating him and starting emergency release blood.” Your medics and nurses start feeding you more information.

“Directive-Descriptive-Informative Communication” Leadership in action:

“Medic Smith, bring the airway cart in here, we will be intubating to protect his airway.”

“Read Files” give current need-to-know information. You want to start the massive transfusion protocol and recall from today’s Read File exactly how to initiate it.

Well done! You are the resuscitationist. You just brought order to chaos; you’ve tamed your own epinephrine surge and you’ve given your team leadership and confidence. You have a vector, and you are now ready for the rest of this challenge.

Now, I understand there may be skeptics. Also, I recognize that “aviation concepts in medicine” is not a panacea, and won’t work for every situation. However, over the years I’ve truly come to appreciate the wisdom embodied in my training as a fighter pilot and I’ve incorporated that into my practice as an EP. I’m convinced these concepts have saved lives in my ED, and hopefully, they can help you in yours.

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Sepsis Gets an Upgrade

Systemic Inflammatory Response Syndrome (SIRS) is something that has been beaten into the heads of medical students, residents, fellows, and all physicians in general. However, the derivation of SIRS occurred in 1991, where the focus was on the then-prevailing inflammatory response of the host immune system. In 2001, a task force recognized the limitations of these definitions but did not really offer alternatives due to a lack of supporting evidence. What we have been left with is the definitions of sepsis being largely unchanged for more than 2 decades, until now. Enter Sepsis 3.0.

The European Society of Intensive Care Medicine and The Society of Critical Care Medicine convened a task force of 19 critical care, infectious disease, surgical, and pulmonary specialists in Jan 2014.

When compiled, the task force recommendations with supporting evidence, including original research, were circulated to major international societies and other relevant bodies for peer review and endorsement (31 endorsing societies).

Issues Addressed

  • Differentiation of sepsis from an uncomplicated infection
  • Update definitions of sepsis and septic shock
  • Recognition that sepsis is a syndrome without at present, a validated criterion standard diagnostic test, leading to major variations in reported incidence and mortality rates
  • Identify clinical criteria that identify all the elements of sepsis (infection, host response, and organ dysfunction). This should be simple to obtain, available promptly and at a reasonable cost.
  • Provide a more consistent and reproducible picture of sepsis incidence and outcomes.

Identified Challenges and Opportunities

  • There is no gold standard diagnostic test that exists to diagnose sepsis. Instead, it is a constellation of clinical signs and symptoms in a patient with suspected infection.
  • The original concept of sepsis as infection with at least 2 of the 4 SIRS criteria focused solely on inflammatory excess, but may also be present in the absence of infection entirely.
  • The use of 2 or more SIRS criteria to identify sepsis was unanimously considered by the task force to be unhelpful. In addition, it has been shown that 1 in 8 patients admitted to critical care units with infection and new organ failure will not have a minimum of 2 SIRS criteria to fulfill the definition of sepsis.
  • The severity of organ dysfunction has been assessed with various scoring systems, however, the predominant score in current use is the Sequential Organ Failure Assessment (SOFA) Score. Simply put the higher the SOFA score, the increased probability of mortality. The score does require many laboratory variables including PaO2, platelet count, creatinine level, and bilirubin for full computation.

SOFA Score

Results/Recommendations:

  • Sepsis is now defined as life-threatening organ dysfunction caused by a dysregulated host response to infection
  • Organ dysfunction can be identified as an acute change in total SOFA score ≥2 points due to the infection (The baseline SOFA score can be assumed to be zero in patients not known to have preexisting organ dysfunction)
  • A SOFA score ≥2 reflects an overall mortality risk of approximately 10% in a general hospital population with suspected infection
  • Screening Patients Likely to Have Sepsis: Patients with a suspected infection that are likely to have a prolonged ICU stay or to die in the hospital can be promptly identified at the bedside with qSOFA (i.e. Altered mental status, systolic blood pressure ≤100mmHg, or respiratory rate ≥22/min). The qSOFA score is less robust than a SOFA score of 2 or greater, but it does not require laboratory tests and can be assessed quickly and repeatedly.

qSOFA

Septic Shock

Patients with septic shock can be identified with a clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain MAP ≥65mmHg and having a serum lactate level >2mmol/L (18mg/dL) despite adequate volume resuscitation. With these criteria, hospital mortality is in excess of 40%

Controversies/Limitations

  • Sepsis is a broad term being applied to an incompletely understood process, therefore pragmatic compromises were necessary placing emphasis on generalizability
  • Initial retrospective analysis showed that qSOFA could be a useful clinical tool for screening of sepsis. It only uses clinical examination findings, but still needs prospective validation to confirm its robustness and possible incorporation into future iterations of the sepsis definitions.
  • Neither qSOFA nor SOFA is intended to be a stand-alone definition of sepsis and that failure to meet 2 or more qSOFA or SOFA criteria should not defer investigation or treatment of infection or delay any other aspect of clinical care
  • Some of the task force argued that lactate measurement should be mandated as an important biochemical identifier of sepsis in an infected patient. Since lactate measurement was not listed alongside the simple bedside criteria, should not constrain the monitoring of lactate as a guide to therapeutic response or as an indicator of illness severity.
  • The focus of this update of definitions was on adult patients, and there is still a need to develop similar updated definitions for pediatric populations
  • This document was not endorsed by all societies (i.e. Latin American Sepsis Institute, American College of Chest Physicians, and American College of Emergency Physicians)
  • There were no members from the low and middle-income countries on the task force, which is important as they had minimal input and sepsis care is different in these settings.

Discussion

Lactate level is a sensitive, but nonspecific, stand-alone indicator of cellular or metabolic stress rather than “shock.” But the combination of hyperlactatemia with fluid-resistant hypotension identifies a group with particularly high mortality and thus offers a more robust identifier of the physiologic and epidemiologic concept of a septic shock than either criterion alone. SIRS is non-specific and now no longer used for sepsis recognition/screening, but patients with SIRS criteria are still potentially critically ill patients.

Clinical Take Home Points

  1. Sepsis = Life-threatening organ dysfunction caused by a dysregulated host response to infection
  2. Septic Shock = Need for Vasopressors AND Lactate >2 mmol/L
  3. Severe Sepsis is OUT
  4. SIRS is OUT and qSOFA/SOFA is IN

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Critical Shortages of Supplies and Qualified Personnel During the COVID-19 Pandemic is Taking a Toll on the Nation’s Clinical Laboratories says CAP

As demand for SARS-CoV-2 coronavirus testing increases, leaders of the College of American Pathologists meet online to brainstorm possible solutions to the crisis In September, the College of American Pathologists (CAP) began its series of “virtual media briefings” given by leading pathologists and physicians at the forefront of COVID-19 testing which is designed to “offer insights and straight talk” on the crisis confronting today’s clinical laboratories.

During the third virtual meeting on December 9, presenters discussed how the ever-increasing demand for COVID-19 testing has placed an enormous amount of stress on clinical laboratories, medical technologists (MTs), and clinical laboratory scientists (CLSs) responsible for processing the high volume of SARS-CoV-2 tests, and on the supply chains medical laboratories depend on to receive and maintain adequate supplies of testing materials.

The CAP virtual meetings, collectively titled, “The Rapidly Changing COVID-19 Testing Landscape: Where We Are/Where We Are Going,” are available for viewing on YouTube and Facebook.

Critical Supply Chain Deficiencies Hamstring Nation’s Clinical Laboratories

“As soon as we get one set of supplies, then it’s another set of supplies that we can’t get our hands-on,” said Christine Wojewoda, MD, Clinical Pathologist and Associate Professor at the University of Vermont Medical Center, during the third CAP virtual briefing. “Right now, we’re very concerned that our lab can’t get pipette tips that have a certain filter in them to transfer patient samples into the tubes that we need, or the plates that we need to do the testing. If we can’t get the patient sample into where it needs to go, safely, without contaminating other patient samples, that’s a big issue.”

Other members of the CAP panel concurred with Wojewoda and indicated that their clinical labs also are encountering supply chain challenges.

“It’s a daily battle,” said Amy Karger, MD, Ph.D., Clinical Pathologist and Associate Professor at University of Minnesota Physicians. “One of our managers spends hours a day making sure our lab has enough supplies, plastics, and chemicals to do the testing that we want to do. And he is often having to look for alternative solutions for COVID-19 testing, making phone calls, trying to find alternative products, and so we have a consistent worry about that.”

A June survey of CAP-accredited laboratories for COVID-19 testing found that more than 60% of lab directors reported difficulties in procuring critical supplies needed to conduct COVID-19 testing. The respondents indicated they encountered substantial barriers to obtaining equipment needed for SARS-CoV-2 testing—particularly test kits (69%), swabs (66%), and transport media (62%).

Staff Burnout and Shortages at Many Medical Laboratories

Karger also indicated that she is concerned about staff burnout and the toll the workload is taking on medical technologists at her laboratory.

“Lab staff have been working full throttle since March. I think that is often lost on people. They kind of assumed that when cases were low with COVID-19, that maybe the lab staff got a break. Well, that wasn’t the case,” she stated, adding, “They [the medical technologists] were planning for this surge that we’re experiencing now and have been working often seven days a week, double shifts to get us to this point of high testing capacity [to respond to the demand for COVID-19 testing].”

Another member of the CAP panel echoed Karger’s concerns.

“We worry about that as well,” said Patrick Godbey, MD, Founder and Laboratory Director at Southeastern Pathology Associates and current CAP President. “This demand for COVID-19 testing has made an already bad situation worse because there’s an absolute shortage of medical laboratory personnel and the increased demands on clinical labs have made this shortage even more acute.”

Almost all of the surveyed CAP-accredited laboratories reported losses in revenue and financial stress since the pandemic started. But few had applied for any of the available funds offered through federal assistance programs. The survey found that the top issues among pathologists reported by laboratory directors were:

  • reduced work hours (72%),
  • reductions in pay (41%),
  • increased burnout (21%), and
  • increased work hours (20%).

According to the survey, the top stresses affecting non-pathologist professionals working in clinical labs were:

  • reduced work hours (69%),
  • reduced staff capacity (36%),
  • temporary furloughs (34%), and
  • increased burnout (31%).

‘An Overwhelming Sense of Doom’

Of course, clinical laboratory managers have been dealing with the dwindling availability of qualified personnel for years, as one medical technologist training program after another closed and the supply of MTs and CLSs tightened. Dark Daily’s sister publication The Dark Report covered this trend as far back as 2012. (See, “GHSU Graduates Med Techs Using Distance Training: Medical Laboratory Scientist training program helps laboratories to recruit and to train MLSs.)

The diminishing labor pool trained for COVID-19 testing—coupled with high stress/burnout among existing staff—is a major impediment to ongoing expansion in the daily number of molecular COVID-19 tests that can be performed by the nation’s labs.

Also, the already-tight supply of med techs means many metropolitan area labs—particularly hospital labs—are operating with just 75% of the number of staff they are authorized to hire because there are no techs available. Thus, existing staff are working lots of overtime, and vacant FTE positions are being temporarily filled by MTs placed by employment agencies.

New York Times (NYT) article in December, titled, “‘Nobody Sees Us’: Testing-Lab Workers Strain Under Demand,” revealed that testing teams across the country are dealing with “burnout, repetitive-stress injuries, and an overwhelming sense of doom.” The article reported on the shortages of supplies needed to perform testing and states there is a “dearth of human power” in the field of pathology as well.

The supply of MTs and CLSs, molecular PhDs, clinical pathologists, MLTs, and other laboratory scientists available to work in the nation’s labs is finite and training programs take years to produce qualified workers to perform laboratory testing.

Should Clinical Lab Workers Be First to Receive the COVID-19 Vaccine?

In the third CAP virtual media briefing, the panel suggested that medical laboratory workers should be among the first to receive the COVID-19 vaccine.

“They are encountering and handling thousands of samples that have the active live virus in them,” Karger said. “We are getting 10,000 samples a day [for SARS-CoV-2 testing]. That’s a lot of handling of infectious specimens and we do want them to be prioritized for vaccination.”

She added, “From an operational standpoint, we need to keep our lab up and running. We don’t want to have staff out such that we would have to decrease our SARS-CoV-2 testing capacity, which would have widespread impact on our health system and our state.”

Since the pandemic began nearly a year ago, there have been more than 18 million cases of COVID-19 confirmed in the US and more than 300,000 people have died from the virus, according to data from the federal Centers for Disease Control and Prevention (CDC).

And, as we move into flu season, the number of new COVID-19 cases is reportedly increasing, which adds more stress to clinical laboratories and their supply chains. As this is unlikely to end anytime soon, clinical lab managers must find new ways to do more with less.

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Autopsies Clearly Help Pathologists Understand COVID-19 and How It Affects the Body, So Why Are More Not Being Performed?

Payers are unwilling to reimburse for autopsies despite the fact that autopsies are a proven way to learn more about new diseases and how they attack the human body Each year, less money is spent by Medicare and private health insurers on autopsies. However, autopsies regularly provide pathologists with relevant, clinically useful information about exact

causes of death and other elements of disease in the deceased. Some diseases cannot be identified any other way but by autopsy. And data from autopsies have helped developers bring critical new medical laboratory tests, therapeutic drugs, and vaccines to market.

Thus, the healthcare system is losing valuable research that would bring a better understanding of diseases and processes in the body that contribute to poor health and death. This is true with COVID-19. Autopsy results have already provided revelations into how the SARS-CoV-2 coronavirus affects the body and yielded clues that are helping pathologists combat the illness.

Looking Closely at Death from COVID-19

“You can’t treat what you don’t know about,” Alex Williamson, MD, an anatomic/clinical/pediatric/forensic pathologist at Northwell Health in New York and Associate Professor of Pathology at Zucker School of Medicine at Hofstra/Northwell, told the Associated Press (AP), ABC News reported in “The Autopsy, a Fading Practice, Revealed Secrets of COVID-19.”

“Many lives have been saved by looking closely at someone’s death,” he added.

Autopsies performed on deceased patients could help clarify why there is such a wide array of symptoms for those affected by COVID-19 and provide details that cannot be detected in living patients.

For example, autopsies completed early in the pandemic confirmed that the SARS-CoV-2 coronavirus causes respiratory disease and that extended use of ventilators could cause considerable damage to the lungs, the AP article noted. This discovery led physicians to re-evaluate how ventilators should be used on COVID-19 patients.

The AP story also stated that pathologists learned the SARS-CoV-2 coronavirus may spread the illness to other organs such as the heart, brain, liver, kidneys, and colon.

Through autopsies, COVID-19 patients also were discovered to have dramatic blood clotting issues in almost every organ of the body and micro-clotting in the lungs.

“The clotting was not only in the large vessels but also in the smaller vessels,” said Amy Rapkiewicz, MD, an anatomic and forensic pathologist, Chair of the Department of Pathology at NYU Langone Medical Center, and Associate Professor, Department of Pathology at NYU Long Island School of Medicine, in an Advisory Board Daily Briefing. “And this was dramatic because though we might have expected it in the lungs, we found it in almost every organ that we looked at in our autopsy study.”

Doctors are now exploring whether blood thinners should be utilized to prevent blood clots from forming in COVID-19 patients.

Autopsies Identify Secondary Causes of Death

Autopsies also have shown that some COVID-19 patients are dying from secondary bacterial infections that appear alongside the disease. This discovery may help doctors understand lingering symptoms that plague some coronavirus patients.

“What you see at autopsy represents an effective catalog of the injury that occurs in patients who have COVID,” pathologist Stephen Hewitt, MD, Ph.D., associate research physician, Laboratory of Pathology, and head of the Experimental Pathology Laboratory at the National Cancer Institute Center for Cancer Research, told Undark. “And it gives you an understanding and a basis to try and forecast forward what we’re going to see in post-COVID syndrome.”

Shortage in Funding and Forensic Pathologists

With advances in technology, clinical laboratory testing, and imaging scans, autopsies are performed much less than they were in the past. In the 1950s, autopsies were performed on about half of the patients who passed away in hospital situations, but now that number is somewhere between only five and 11%, ABC News reported.

At this time, hospitals are not required to provide autopsy services and the costs to perform autopsies are often not covered by private or government insurance.

“As medicine has become closer to the bottom line, community hospitals don’t want to perform the autopsies because they’re not getting any functional reimbursement for them,” Hewitt told Undark.

Hospitals usually have to cover costs associated with autopsies themselves or pass those expenditures along to the deceased patient’s family. Autopsies typically cost anywhere from $1,000 to $5,000 per patient, Undark reported.

“When you consider there’s no reimbursement for this, it’s almost an altruistic practice,” Billie Fyfe-Kirschner, MD, a pathologist with Rutgers University, told the Associated Press. “It’s vitally important, but we don’t have to fund it.”

According to the AP, the US faces a critical shortage of forensic pathologists who are trained to perform autopsies. It is estimated, AP reported, that “the US has only a few hundred forensic pathologists but could use several thousand—and less than one in 100 graduating medical school students enters the profession each year.”

Clearly, pathologists have much to offer in the field of autopsies. Autopsying patients who died from COVID-19 may provide data that could greatly affect treatment for those diagnosed with the disease and improve patient outcomes overall.

 

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ToeMate Nail Soak Fungus Treatment Kits

Penetration

For the medication to penetrate and reach the infection through nail keratin (which absorbs water and repels water insoluble drugs) the treatment must be at least partially water soluble. The most effective way is to immerse the infected nails in an antimicrobial that is dissolved in water to give nails absorption time. Of the 125 or so treatments for nail fungus, only three are at least partially water soluble (Kerydin, Loceryl and ToeMate Nail Soak).

Scientifically, nail keratin is hydrophilic and Kobayashi et al 1999 found that the permeation through nail keratin of a water soluble drug was much greater than a non-water soluble drug of similar molecular weight by a ratio of 90 to 1.

Energy

When nails soften in a warm shower, they’re absorbing water. Water uses heat energy to penetrate the nail but most medications are applied at room temperature. This means that most medications lack the energy to penetrate the nail. Of the 125 or so treatments for nail fungus, only one uses additional energy to help penetrate (ToeMate Nail Soak).

Scientifically, Gupchup-Malhotra et al 2000 determined the energy necessary to drive the permeation of water through a normal nail is 7.2 kcal/mole. All but one of the currently available therapies (ToeMate Nail Soak – 7.7 kcal/mol) are applied at room temperature (about 0.5 kcal/mol).

Nail thickness

Infected nails become thicker as the infection spreads making it more difficult for the medication to penetrate. To thin the nail, a cleaner can be applied to remove the excess nail and facilitate the delivery of the medication. ToeMate Kits include a cleaner that breaks up the infection creates micro-channels to help the thermal solution penetrate deeper into the nail.

Scientifically, as keratin debris accumulates, the nail becomes thicker and increases the barrier to treatment. Kobayashi 2004 found that nail penetration decreases linearly with increasing nail thickness. Quintanar 1998 found that the application of a topical keratolytic reduces nail thickness and the energy required for penetration. Keratolytics such as salicylic acid, papain, and urea are available OTC under brand names Zanaquick and Gold Cosmetics. Salicylic acid 30% is included in ToeMate Kits.

Electrostatic repulsion

Just like two magnets that repel each other, the nail plate repels medication that prevents it from penetrating (since most antifungal medications were developed to penetrate skin, not nail). To reduce repulsion and increase penetration, ToeMate kits include a neutralizer that reduces the repulsion and allows the medication to penetrate the nail.

Scientifically, also known as the Donnan effect, Kobayashi 2004 found that electrostatic repulsion further inhibits nail permeability between the keratin membrane and the diffusing molecule. QAC, a cationic antimicrobial surfactant used in ToeMate Kits reduces or eliminates the repulsion and allows the diffusing molecules to enter more readily (Unhoch 1997).

Antifungal strength

Modes of action are the mechanisms antifungal medications use to eliminate infections (e.g., attack cell membrane, disrupt DNA or protein synthesis). Of the 125 antifungal medications, only two have more than one mode of action (cyclopirox and ToeMate Nail Soak) and only the latter disrupts spore development (without it infections reoccur).

Scientifically, research from Baran et al 2005 suggests that combination therapies that use two or more antimycotics with complimentary modes of action lowers overall MIC values (disabling many cellular functions simultaneously) compared to values for the antimycotics applied individually. Infections with combinations of dermatophytes, yeasts, and molds are thought to be common but difficult to diagnose (Elewski et al 2015). Ciclopirox and ToeMate Nail Soak demonstrate more than one mode of action and ToeMate exhibits activity against spore outgrowth that prevents reinfection.

Safety

Salicylic acid, PHMB and QAC, the active ingredients in ToeMate Kits, and have been safely used in dermatology, cosmetics and public water treatments for the last sixty years.

Reduced Treatment Times & Expense

Combining ToeMate’s benefits into one treatment shortens the protocol down from 18 to 3 months or less (depending on the severity) with a simultaneous cost reduction per ounce from $4,700 for Kerydin to about $0.50 per ounce for ToeMate.

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Zanidatamab Active in HER2-Positive Biliary Tract Cancer

The bispecific HER2-targeted antibody zanidatamab was found to safely induce durable antitumor activity in an expansion cohort of patients with HER2-overexpressing biliary tract cancer (BTC). Data from the phase 1 study’s (ClinicalTrials.gov identifier: NCT02892123) expansion cohort were presented at the 2021 Gastrointestinal Cancers Symposium by Funda Meric Bernstam, MD, chair of the department of investigational cancer therapeutics at The University of Texas MD Anderson Cancer Center in Houston.

Twenty of the 21 patients included in the cohort were available for response, and tumor shrinkage was observed in most of them. The confirmed objective response rate was 40% (95% CI, 19.1-63.9), with 8 patients achieving a partial response. The disease control rate was 65%, and the median duration of response was 7.4 months.

In the dose-escalation part of the phase 1 study, the investigators identified 20 mg/kg of zanidatamab administered every 2 weeks as the recommended dose. This dose was used in the expansion cohort of 21 patients. Tumors were assessed every 8 weeks.

The median patient age was 63 years, and 67% of patients were female. Gallbladder cancer was the most common diagnosis (57%), followed by intrahepatic cholangiocarcinoma (24%) and extrahepatic cholangiocarcinoma (19%). Twenty-four percent of patients received prior HER2-targeted therapy.

Regarding safety, zanidatamab was found to be well-tolerated. No patient experienced a grade 3 or higher drug-related adverse event (AE). One zanidatamab-related serious AE, grade 2 fatigue, was observed in 1 of the trial participants. Two deaths were reported during the study; 1 was due to progressive disease and the other, to an AE not related to zanidatamab therapy.

All patients experienced treatment-emergent adverse events, the most common of which were diarrhea (43%) and infusion-related reactions (33%).

“Based on these results, zanidatamab has the potential to address an unmet needs in patients with HER2-positive biliary tract cancer,” Meric-Bernstam concluded.

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