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Cancer Centers Rebounding From COVID-19 Can Grow By Making the Most of New Technologies for Clinical Trials

For community cancer centers that rely on patient reimbursement to stay afloat, a smart data-driven approach to clinical trials provides a foundation for future growth.

Brenda Noggy
Dr. Tandy Tipps

By TANDY TIPPS and BRENDA NOGGY

Covid-19’s tragic, devastating impact on cancer treatment is now well documented. Cancer screenings dropped by almost 90 percent at the peak of the pandemic. Billing for some leading cancer medications dropped 30 percent last summer. Studies found a 60 percent decrease in new clinical trials for cancer drugs and biological therapies.

Cancer centers, like every part of the US health system, have a lot of ground to make up. Those community cancer centers without grants and other institutional advancement funds, experience financial and human resources as major constraints to charting a path to growth. For them, successful programs which generate revenues for expansion or break even help them maintain fiscal health. Often, unfortunately, too often their research programs lose money.

Clinical trials have not been a viable revenue source because of the difficulty in accurately predicting patient enrollment and the challenges of managing trial portfolios, a task that requires streamlined feasibility processes that include querying baseline populations for new trials and potentially eligible patients.

The hard work of patient screening and trial matching requires clinical coordinators, physician investigators and research support staff to spend between three to eight manually scouring databases of electronic medical records and unstructured files to find patients eligible for trials based on increasingly complex inclusion and exclusion criteria. This costly process does not take into consideration the pre-screening efforts in patient matching that may not be reimbursable.

Resources are also needed to implement feasibility processes to accurately predict how many patients might enroll in a trial if they are eligible. Most community-based sites do not have an accurate ability to query their current patient populations by disease cohort or mutation in real time. They often rely on physicians’ memories to estimate patient numbers for trial feasibility questionnaires, which must returned to sponsors quickly, usually before cancer centers have definitive recruitment numbers.

As a result, before COVID, an average of only 5 percent of patients had a chance of participating in trials, 50 percent of clinical trials failed to meet enrollment goals and less than 14 percent were completed on time. Cancer centers still incur the administrative and clinical resources required to maintain the protocols in the first place, however.

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Did Covid and Telemedicine Finally Make the Physical Exam Obsolete?

By HANS DUVEFELT

Left to my own devices, I would be selective about when and how much of a physical exam I do: either not at all or very detailed for just those things that can help me make the diagnosis. I have no patience for boilerplate normal exams. Any doctor who uses the term PERRLA (pupils equal, round, reactive to light and accommodation) is probably faking it. First, most of the time this isn’t actually tested completely and, second, even if it’s done correctly, it has no relevance in the majority of chart notes I have found it in. I have actually seen it in office note templates for urinary tract infections!

It is well known that the history makes the diagnosis in the vast majority of cases. But that task – or art, actually – is sometimes relegated to support staff or forced into unnatural click boxes. Because reimbursement until very recently was tied to how many items were asked about and examined, there was a loss of the story, or narrative, of the patient’s illness. And you could get more brownie points by including things that were extremely peripheral to the clinical problem at hand.

EMRs make it easy to produce long office notes with lots of reimbursement and quality scoring points of uncertain clinical value and accuracy.

Specifically, the physical exam has in many instances become a corrupted, fraudulent, one-click travesty of the art and professionalism we swore an oath to hold high when we graduated from medical school.

The pandemic and the rush toward telemedicine made it clear to most people that medical diagnosis, advice and treatment is entirely possible without physical contact. It was just a matter of getting paid for it, or the healthcare industry would have come to a stop, or at least a crawl.

Now that we have admitted that listening, talking and a certain amount of looking or observing can be done without being in the same room, it is time for us to be honest about the value of the physical exam.

Our medical education in universities and tertiary medical centers taught us how to handle complex and baffling cases that had eluded diagnosis in the primary care setting: Start from scratch, assume nothing. This is a method we need to use in select clinical situations.

But in everyday practice that is inefficient and unnecessary. Most of what we see is simple stuff and part of our job is to triage, to know when something seemingly ordinary is or has the potential to be more serious.

We need to know how to do a really good and relevant physical exam when the situation requires it. But we also need to know when that would add nothing and only waste our time and effort.

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The “Health Tech Responds to COVID-19” Showcase Webinar!

By ELIZABETH BROWN

Catalyst @ Health 2.0 is excited to be hosting the Health Tech Responds to COVID-19 Showcase Webinar, sponsored by the Robert Wood Johnson Foundation! A little under a year ago, Catalyst, with the support of the Robert Wood Johnson Foundation, launched the “Health Tech Responds to COVID-19” platform to maximize the health tech community’s response to the pandemic. The platform features an “Always on” Rapid Response Open Calls (RROCs); a blog/informational website to showcase innovators and experts in this space, and the development of a comprehensive database that allows the public to search and filter for innovative solutions – SourceDB for COVID-19.

With RWJF’s support, Catalyst has opened up the platform to the larger digital health ecosystem and sought organizations interested in sourcing novel technologies, both COVID-19-specific and those with a broader scope. In this video, we hear from some of our Rapid Response Open Call hosts and participants as well as some special guests like John Brownstein discussing VaccineFinder and Jacob Reider talking about the problems of how to manage the vaccine process among the underserved. This is a great discussion of past, present, and future opportunities that have emerged with the global pandemic.

Elizabeth Brown is a Program Manager at Catalyst @ Health 2.0

Correlative Adventures with COVID

By ANISH KOKA

“The patient in room 1 should be a quick one, its an addon, they just need a prescription for ivermectin”

I’m a bit puzzled by this sentence from my assistant doing his best to help me through a very busy day in the clinic that I’m already behind in. I walk into the room, a script pad stuffed into my hand as I enter the room, to meet a very nice couple.  The wife sits patiently with hands crossed on the exam table. 

“So, you’re here for Ivermectin?”, I ask.

Why yes, a trip to Texas is planned.. COVID is in the air, the internet, and some important people who have ‘inside knowledge’ have raised doubts about the vaccine.  Some other people who quite possibly could be the same people, have also suggested prophylactic ivermectin is the better bet to prevent these good people from catching COVID.

Ivermectin is a drug  known to work against parasites.  The virus angle relates to in vitro data that suggests Ivermectin inhibits the host importin alpha/beta-1 nuclear transport proteins, which are part of a key intracellular transport process that viruses use to enhance infection by suppressing the host’s antiviral response.  In addition, ivermectin may interfere with the attachment of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein to the human cell membrane. Ivermectin demonstrates a broad spectrum of activity in-vitro against a variety of viruses like dengue, Zika, HIV, and yellow fever.  Unfortunately, despite this in vitro activity, no clinical trials have reported a clinical benefit for ivermectin in patients with these viruses.

Ivermectin does inhibit Sars-Cov2 viral replication in cell cultures.  However, pharmacokinetic studies suggest that achieving the plasma concentrations necessary for the antiviral efficacy detected in vitro would require administration of doses up to 100-fold higher than those approved for use in humans. Even though ivermectin appears to accumulate in the lung tissue, predicted systemic plasma and lung tissue concentrations are much lower than 2 µM, the half-maximal inhibitory concentration (IC50) against SARS-CoV-2 in vitro. Subcutaneous administration of ivermectin 400 µg/kg had no effect on SARS-CoV-2 viral loads in hamsters, though there was a reduction in olfactory deficit and a reduction in the interleukin (IL-6:IL-10) ratio in lung tissues.

Since the pandemic began, there have been a number of small randomized controlled trials of ivermectin in mild COVID patients that show more rapid viral clearance, but not too much else.   The prophylaxis data is considerably more sparse, and is of the retrospective variety.  Basically take a number of countries that use Ivermectin variably and compare the incidence of COVID in those countries. 

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Modern Day “Victory Gardens” – Planting the Seeds for Covid Vaccination Success

By MIKE MAGEE

In the wake of Pearl Harbor, FDR found our nation ill-prepared for war. He lacked manpower and tools. In response, he took deliberative action with the support of Congress, drafting soldiers and redirecting supply chains toward weapons of war. Compliance was requested, then demanded. Those industries that served, including Pfizer with penicillin production, benefited in the short and long-term.

FDR not only harnessed the power of industry and science, and ramped up the military, but also asked every family and every community to participate in the war effort. Community volunteering soared, and sacrifice for the public good was the rule, not the exception.

One idea was “victory gardens”, planted in back yards,  to allow stressed food manufacturers the ability to focus on meeting the demand to “feed the troops.”  These gardens in 1943 provided 1/3 of all the vegetables consumed in the states that year.

President Biden now finds himself in a similar predicament – the need to redirect our vast industrial productive capacity while mobilizing our citizens to both support and participate in vaccination efforts.

Our President and his team understand that interventional and privatized high science is of little avail if that science (in this case vaccines) is unable – by limited supply or logistic ineptitude or the absence of public trust – to find it’s way efficiently and quickly into the arms of our citizens.

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Critical Care Nurse Shortage During COVID-19 Pandemic: A Call for Nurse Anesthesia Students to Bedside

By TONYCHRIS NNAKA

In March of 2020, when we had limited knowledge on the infectivity and virulence of the virus that causes COVID-19, I joined a team of critical care nurses who were willing to risk their lives to care for those suffering from COVID-19. As a full-time PhD student in nursing, a new parent to my infant son, a primary caregiver to my 73-year-old mother, and as someone with a known history of severe asthma, I knew that I was embarking on a journey that could potentially cost me my professional and personal dreams and endanger those I care for the most in life: my family. My intentions to practice only part-time as a critical care nurse while pursuing full-time studies were halted after only two weeks of managing critically ill COVID-19 patients early in the pandemic. The countless code blues and unprecedented levels of patient deaths made it clear that we were in uncharted territory.  After seeing the pain and fear on the faces of my nursing peers, I knew I could never leave them behind in this new battlefield. So, I stayed at bedside full-time for a year while also maintaining my full-time status as a PhD student. I had to. I could not turn my back on my practice oath, or my future professional goals as a nurse scientist. It is in this spirit that, on behalf of myself and my exhausted colleagues, I call on those with critical care experience who have stepped away from bedside to return, as they are able, and answer this same call to action. 

The extent of the critical care nursing shortage we are currently experiencing is alarming to me and almost beyond my comprehension. This shortage has forced critical care nurses who have been at bedside since March of last year to remain at bedside even as several of us have reached the breaking point of psychological exhaustion. Our desperate outcry for backup from our fellow critical care nurse colleagues seems to have yielded no outcome. It is obvious that addressing this shortage would require a solution with immediate implementation as we do not have time for the training of more critical care nurses. Thus, an immediate call to all nurse anesthesia students to return to bedside should be a part of any strategy geared towards quickly addressing issues of this critical care nursing shortage.

At a time when the role of critical care registered nurses is most needed, several nurse anesthesia programs continue with their regular admission cycle protocol: pulling critical care nurses away from bedside. At my current hospital, we lost nearly a dozen critical care nurse colleagues to nurse anesthesia programs between March and May of 2020 at the peak of the pandemic. Since the nurse anesthesia program requirements stipulate a minimum of one year of critical care nursing experience, all program applicants possess highly specialized clinical skills needed for the care of critically ill COVID-19 patients.  While there are unarguable reasons as to why some nurse anesthesia students have yet to answer this urgent call to duty, we as a profession, and as a society must do what we can to incentivize them to return to bedside to help relieve the suffering of patients and exhausted nurses who have fought tirelessly at the frontlines since the onset of the pandemic – many of whom have lost their lives as a result. 

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Medable’s CEO: Covid19 Vaccine Will Start Big Pharma’s Era of De-Centralized Clinical Trials

By JESSICA DaMASSA, WTF HEALTH

Covid 19 vaccine development may have mainstreamed questions about how to hasten drug development timelines, but Medable, a health tech startup that offers researchers a way to de-centralize clinical trials, has been working to solve this problem for five years. Freshly funded with a $91M Series C raise, co-founder and CEO Michelle Longmire talks through the benefits of “liberating” clinical trials from academic research centers and sending them onto devices into patient’s homes. Traditionally, drug development processes average more than 10 years, cost millions of dollars, and are limited in the diversity of patients they can recruit because of the heavy focus on the geographic location of the research team conducting the trial. Medable’s digital platform breaks these limitations, reducing drug development timelines and costs by making it easier for researchers to draw study participants from anywhere. More importantly, it makes the novel medicines being tested by the trial available to a bigger, more diverse array of patients. Despite the gains made in 2020 toward the de-centralized clinical trial model (Medable’s revenue shot up 500%), there’s concern that Big Pharma may return to the business processes of old once the pandemic is under control. Does Michelle think last year make enough of an impact to change their business model for good? Find out what’s ahead for the future of pharma.

Catalyst @ Health 2.0 & AFBH Launch Call For COVID-19 Vaccine Scheduling

By ELIZABETH BROWN

Attention digital health innovators! Do you have a health tech solution that can aid community-based care coordinators in COVID-19 vaccine screening and appointment scheduling for their underserved and vulnerable patients? Apply to the second Alliance for Better Health Rapid Response Open Call, hosted by Catalyst @ Health 2.0 & sponsored by the Robert Wood Johnson Foundation!

As the COVID-19 pandemic continues, the importance of ensuring health equity and access is vital. This RROC is looking for solutions to help community care coordinators and providers schedule appointments for COVID-19 vaccines for vulnerable and underserved patients who may be facing barriers to self-scheduling those vaccine appointments. The intended care providers are those working with patients who may lack resources, health literacy, or face other barriers to self-scheduling appointments. A select group of semi-finalists will have the opportunity to demo their technology. A grand prize winner will receive $15k and the opportunity to collaborate with Alliance for Better Health! 

Do you have a solution that can fit this need? Apply HERE today! Applications close 2/2.

(This is the second of 2 COVID-19 RROC challenges from Alliance for Better Health. The first was for vaccine administration tracking announced on Tuesday 19th. Both are mentioned in the video from Jacob Reider, Alliance for Better Health’s CEO, which you can see below)

CEO Jacob Reider introduces the challenges

About Alliance For Better Health: Alliance For Better Health engages medical and social service providers in developing innovative solutions to promote people’s health, with a goal of transforming the care delivery system into one that incentivizes health and prevention. Established in 2015 as a Performing Provider System in the New York State Delivery System Reform Incentive Payment program (DSRIP), Alliance partners with more than 2,000 providers and organizations across a six-county area in New York’s Tech Valley and Capital Region.  

Elizabeth Brown is a Program Manager at Catalyst @ Health 2.0

Catalyst @ Health 2.0 & AFBH Launch Call For COVID-19 Vaccine Administration Tracking

By ELIZABETH BROWN

Attention digital health innovators! Do you have a tracking tool that can assist public health care providers in managing the two-phased COVID-19 vaccination administration? Apply to the Alliance For Better Health Rapid Response Open Call for Vaccination Administration Tracking! 

As the COVID-19 pandemic continues, the importance of ensuring health equity in #COVID19 vaccination administration for vulnerable and underserved populations is increasingly critical. Catalyst @ Health 2.0 is proud to host a Rapid Response Open Call (RROC) in collaboration with Alliance For Better Health. A select group of semi-finalists will have the opportunity to demo their technology. A grand prize winner will receive $15k and the opportunity to collaborate with Alliance For Better Health! 

Do you have a solution that can fit this need? Apply HERE today! Applications close 1/31.

(This is the first of 2 COVID-19 RROC challenges from Alliance for Better Health. The second will be announced on Thursday 21st but is mentioned in the video from Jacob Reider below)

CEO Jacob Reider introduces the challenges

About Alliance For Better Health: Alliance For Better Health engages medical and social service providers in developing innovative solutions to promote people’s health, with a goal of transforming the care delivery system into one that incentivizes health and prevention. Established in 2015 as a Performing Provider System in the New York State Delivery System Reform Incentive Payment program (DSRIP), Alliance partners with more than 2,000 providers and organizations across a six-county area in New York’s Tech Valley and Capital Region.  

Elizabeth Brown is a Program Manager at Catalyst @ Health 2.0

Two Surgeons—a Veteran and a Newcomer—Talk Fighting COVID Burnout

By MICHAEL E. LIPKIN and RUSSELL S. TERRY, JR.

Burnout has always been a concern in medicine, and that concern has been amplified by the added stress of COVID-19. Many months into an unpredictable and distressing situation, we have both hung on to our mental health and professional passion by seeking out strategies that work for us. We offer them in two perspectives: veteran and relative newcomer.  

Dr. Lipkin: A Veteran’s Perspective

When lockdown began in March, we slowed down my practice for about 6 to 8 weeks, and then returned to full pre-COVID levels. It feels like the uncertainty has affected me most, since it has not been clear if and when things will get substantially better. Everyone is both experiencing and projecting persistent anxiety, stress and uncertainty. Isolation is a problem as well. I no longer have the time or ability to sit down with colleagues and vent over a beer, which was an outlet I counted on to mitigate burnout. At the same time, on a more concrete level, the pandemic has made everything we do incrementally more difficult, which is grindingly stressful. These tips are helping me cope and avoid burnout.

There are so many changes—just accept them. As COVID affects so many areas of practice, there’s a kind of low-grade stress that fluctuates with events. It seems like everything is a little bit harder. We have to shift some patient visits to telehealth and make sure they get COVID tests before surgery. We’re all looking over our shoulders, wondering who’s going to get us sick. There’s always the specter of more shutdowns and how they might affect our livelihoods. Budgets have been cut back, so hiring is frozen and there’s virtually no incremental spending. Everything will stay this way for now, so the best thing to do is accept that we’re going through a tough period and focus on the big picture, rather than the list of irritations.

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