News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Repositioning the Clinical Laboratory as a Strategic Pillar of the Value-Based Healthcare Organization, Consistent with Clinical Lab 2.0

Panel of experts in healthcare and the clinical laboratory market identify key trends and discuss how innovative medical laboratories are adding value—and getting paid for that value

Effective clinical laboratory leadership in today’s value-based healthcare system means demonstrating value within an integrated delivery network. After all, as fee-for-service payment for clinical lab tests gives way to value-added reimbursement arrangements, all medical laboratories will need to justify their share of a value-based payment.

But how can clinical laboratories alert physicians and their parent hospitals to the real value they offer to improve patient outcomes and reduce healthcare costs? Though lab leaders may understand their medical lab’s complexity, accessibility, and impact, the question is how to direct the effort. The answer lies in a risk that some laboratory directors may not have considered.

Value-based healthcare systems include hospital-based medical laboratories as an essential part of their integrated health system. And, to lower the cost of care, healthcare systems involved in value-based care know they must become better at coordinating care and offering precision medicine services to their patients.

Year-by-year, more integrated health systems are learning how to eliminate gaps in care and become more proactive in delivering care that helps keep patients healthy. However, the task of leveraging the clinical laboratory in a strategic approach to demonstrating value in those health systems remains daunting. One of the goals of the Clinical Lab 2.0 model developed by the Project Santa Fe Foundation clinical laboratory organization is to demonstrate how labs can achieve two goals:

  • Create added-value services that improve patient care; and
  • Have health insurers, accountable care organizations (ACOs), and health networks pay remuneration to the clinical labs for those added-value services.

Pathologists, Clinical Chemists, and MTs Leave Thy Medical Labs

Expert panelists of a recent webinar hosted by Dark Daily and sponsored by Sunquest Information Systems suggested ways that clinical laboratories could better position themselves to be an asset for their organizations. One way to do this is to get their clinical pathologists, PhDs, and medical technologists out of the lab and engaged with physicians, nurses, and other clinical staff in specific ways that influence the healthcare organization’s overall performance in delivering better patient outcomes at less cost.

“If your pathologists aren’t sitting on the medical informatics committee or the clinical quality-improvement committee or any one of the myriad things at the enterprise level, that’s going to be a risk for you,” said Michael J. Crossey, MD, PhD, CEO and Chief Medical Officer for TriCore Reference Laboratories, during the webinar “Listen, Learn, Lead: Uncover Ways You Can Position Your Lab as a Strategic Pillar of the Healthcare Organization.” 

“Our labs have to be equal partners instead of recipients of where things are going,” he stressed. “We need to be, if not in the driver’s seat, at least in the front seat.”

The expert webinar panelists included:

Mark Dixon (above), President of the Mark Dixon Group LLC, moderated the webinar, which was sponsored by Sunquest Information Systems  and The Dark Report, sister publication of Dark Daily. Dixon has more than 30-years’ experience as a health system CEO and COO. He said TriCore and other labs are succeeding at value-based healthcare using methods that are well-defined and available for all clinical laboratories to learn. For example: TriCore has found that certain health insurers are willing to not only pay their laboratory differently, but also meet with the lab’s pathologists and leaders to negotiate value-based care arrangements. (Photo copyright: Mark Dixon Group.)

Fundamental Changes That Will Impact All Clinical Laboratories

The panel speakers discussed how clinical laboratories can strategically position themselves to be successful in today’s evolving healthcare industry. They predicted several fundamental changes would take place or continue. These changes include:

  • A continued shift away from pure fee-for-service payment (volume) to value-based reimbursement that rewards improved patient outcomes;
  • More discussion regarding prevention of illnesses, chronic diseases, and personal responsibility;
  • More focus on primary care and proactive care;
  • Rapid advances in science and technology that will spark development of new healthcare applications;
  • Continued trend toward consumerism, as more patients pay a larger portion of their healthcare expenses and shop for hospitals, doctors, and labs; and
  • Intense cost pressure on healthcare organizations and their medical laboratories.

It was noted during the panel discussion that, even as the US spends more than any other country in the world on healthcare, it has some of the worst overall outcomes.

Customers Rapidly Becoming Stakeholders

“I always think in terms of stakeholders and the number one stakeholder for any clinical laboratory or healthcare system is always the customer,” said Peters. “The lab’s customer is the ordering physician. So, it’s important that labs ‘speak their language’ and understand that the physician’s customer is the patient.”

Clinical laboratories also must be aware of what a particular healthcare system is trying to accomplish. “Lab leaders should stay in constant touch with where the market is, where the system is, and where reform is,” said Oravetz. “And realize there are things that can be done today to set up for what’s coming tomorrow.”

Terese said that for a clinical laboratory to survive during this rapid transformation of the US healthcare system—or at least continue to thrive—it needs to engage with the strategic and clinical initiatives guiding every health system around the country. “There is tremendous opportunity for clinical laboratories to not only support that transition, but to actually help drive it,” he said. “There’s nothing wrong with thinking of your medical laboratory as a leader of these initiatives, versus just as a follower of what the organization is doing.”

Key elements of the webinar that will be of interest to clinical laboratories include:

  • Examples of clinical laboratories navigating the transition from volume to value-based care;
  • Discussion and update on fundamental changes coming to the US healthcare industry that impact clinical laboratories;
  • The case for demonstrating the value of clinical labs to healthcare organizations; and
  • Eight ways to elevate the value of clinical labs within an integrated healthcare network.

The experts on this special discussion panel agree that US healthcare and the clinical laboratory marketplace is in a time of transition. Pathologists and medical laboratory scientists have an opportunity to position themselves as leaders and changemakers to the benefit of patients, as well as their parent hospitals and health networks.

This free webinar can be a critical tool for leadership training within every clinical laboratory. It can be used to give lab managers and lab staff fresh insights into the changes happening in healthcare. Insights that can guide strategic planning and inspire laboratory-led projects to collaborate with physicians and improve patient care.

Download this webinar for free by clicking here. (Or, copy and paste this URL into your browser: https://darkintelligenceprogramsondemand.uscreen.io/programs/listen-learn-lead-uncover-ways-you-can-position-your-lab-as-a-strategic-pillar-of-the-healthcare-organization.)

—JP Schlingman

Related Information:

Free On-Demand Webinar: Listen, Learn, Lead: Uncover Ways You Can Position Your Lab as a Strategic Pillar of the Healthcare Organization

Ochsner Accountable Care Network Recognized Nationally for Quality and Efficiency

Defining Value—The Foundation of Outcomes-Based Risk-Sharing Agreements

Value-Based Contracts with Risk 3 to 5 Years Away for Providers

Humana’s New Oncology Value-Based Care Program Includes Quality and Cost Measurements of Provider Performance, Clinical Laboratories, and Pathology Groups

FDA, IBM, Merck, Walmart and KPMG Collaborate on Blockchain Pilot Project to Track Pharmaceuticals

First used to track cryptocurrencies such as Bitcoin, blockchain is finding its way into tracking and quality control systems in healthcare, including clinical laboratories and big pharma

Four companies were selected by the US Food and Drug Administration (FDA) to participate in a pilot program that will utilize blockchain technology to create a real-time monitoring network for pharmaceutical products. The companies selected by the FDA include: IBM (NYSE:IBM), Merck (NYSE:MRK), Walmart (NYSE:WMT), and KPMG, an international accounting firm. Each company will bring its own distinct expertise to the venture. 

This important project to utilize blockchain technologies in the pharmaceutical distribution chain is another example of prominent healthcare organizations looking to benefit from blockchain technology.

Clinical laboratories and health insurers also are collaborating on blockchain projects. A recent intelligence briefing from The Dark Report, the sister publication of Dark Daily, describes collaborations between multiple health insurers and Quest Diagnostics to improve their provider directories using blockchain. (See, “Four Insurers, Quest Developing Blockchain,” July 1, 2019.)

Improving Traceability and Security in Healthcare

Blockchain continues to intrigue federal officials, health network administrators, and health information technology (HIT) developers looking for ways to accurately and efficiently track inventory, improve information access and retrieval, and increase the accuracy of collected and stored patient data.

In the FDA’s February press release announcing the pilot program, Scott Gottlieb, MD, who resigned as the FDA’s Commissioner in April, stated, “We’re invested in exploring new ways to improve traceability, in some cases using the same technologies that can enhance drug supply chain security, like the use of blockchain.”

Congress created this latest program, which is part of the federal US Drug Supply Chain Security Act (DSCSA) enacted in 2013, to identify and track certain prescription medications as they are disseminated nationwide. However, once fully tested, similar blockchain systems could be employed in all aspects of healthcare, including clinical laboratories, where critical supplies, fragile specimens, timing, and quality control are all present.

The FDA hopes the electronic framework being tested during the pilot will help protect consumers from counterfeit, stolen, contaminated, or harmful drugs, as well as:

  • reduce the time needed to track and trace product inventory;
  • enable timely retrieval of accurate distribution information;
  • increase the accuracy of data shared among the network members; and
  • help maintain the integrity of products in the distribution chain, including ensuring products are stored at the correct temperature. 
In the FDA’s February announcement, Scott Gottlieb, MD (above), the FDA Commissioner at that time, said, “For the drug track-and-trace system, our goals are to fully secure electronic product tracing, which provides a step-by-step account of where a drug product has been located and who has handled it, [and] establish a more robust product verification to ensure that a drug product is legitimate and unaltered.” It’s not hard to imagine how such a tracking system would be equally beneficial in clinical laboratories and hospital pathology departments. (Photo copyright: FDA.)

Companies in the FDA’s Blockchain Pilot

IBM, a leading blockchain provider, will serve as the technology partner on the project. The tech giant has implemented and provided blockchain applications to clients for years. Its cloud-based platform provides customers with end-to-end capabilities that enable them to develop, maintain, and secure their networks. 

“Blockchain could provide an important new approach to further improving trust in the biopharmaceutical supply chain,” said Mark Treshock, Global Blockchain Solutions Leader for Healthcare and Life Sciences at IBM, in a news release. “We believe this is an ideal use for the technology because it can not only provide an audit trail that tracks drugs within the supply chain; it can track who has shared data and with whom, without revealing the data itself. Blockchain has the potential to transform how pharmaceutical data is controlled, managed, shared and acted upon throughout the lifetime history of a drug.”

Merck, known as MSD outside of the US and Canada, is a global pharmaceutical company that researches and develops medications and vaccines for both human and animal diseases. Merck delivers health solutions to customers in more than 140 countries across the globe. 

“Our supply chain strategy, planning and logistics are built around the customers and patients we serve,” said Craig Kennedy, Senior Vice President, Global Supply Chain Management at Merck, in the IBM news release. “Reliable and verifiable supply helps improve confidence among all the stakeholders—especially patients—while also strengthening the foundation of our business.”

Kennedy added that transparency is one of Merck’s primary goals in participating in this blockchain project. “If you evaluate today’s pharmaceutical supply chain system in the US, it’s really a series of handoffs that are opaque to each other and owned by an individual party,” he said, adding, “There is no transparency that provides end-to-end capabilities. This hampers the ability for tracking and tracing within the supply chain.”

Walmart, the world’s largest company by revenue, will be distributing drugs through their pharmacies and care clinics for the project. Walmart has successfully experimented using blockchain technology with other products. It hopes this new collaboration will benefit their customers, as well.

“With successful blockchain pilots in pork, mangoes, and leafy greens that provide enhanced traceability, we are looking forward to the same success and transparency in the biopharmaceutical supply chain,” said Karim Bennis, Vice President of Strategic Planning of Health and Wellness at Walmart, in the IBM news release. “We believe we have to go further than offering great products that help our customers live better at everyday low prices. Our customers also need to know they can trust us to help ensure products are safe. This pilot, and US Drug Supply Chain Security Act requirements, will help us do just that.”

KPMG, a multi-national professional services network based in the Netherlands, will be providing knowledge regarding compliance issues to the venture. 

“Blockchain’s innate ability within a private, permissioned network to provide an ‘immutable record’ makes it a logical tool to deploy to help address DSCSA compliance requirements,” said Arun Ghosh, US Blockchain Leader at KPMG, in the IBM news release. “The ability to leverage existing cloud infrastructure is making enterprise blockchain increasingly affordable and adaptable, helping drug manufacturers, distributors, and dispensers meet their patient safety and supply chain integrity goals.”

The FDA’s blockchain project is scheduled to be completed in the fourth quarter of 2019, with the end results being published in a DSCSA report. The participating organizations will evaluate the need for and plan any future steps at that time.

Blockchain is a new and relatively untested technology within the healthcare industry. However, projects like those supported by the FDA may bring this technology to the forefront for healthcare organizations, including clinical laboratories and pathology groups. Once proven, blockchain technology could have significant benefits for patient data accuracy and security. 

—JP Schlingman

Related Information:

IBM, Walmart, Merck in Blockchain Collaboration with FDA

Pilot Project Program Under the Drug Supply Chain Security Act; Program Announcement

IBM, KPMG, Merck and Walmart to Collaborate as Part of FDA’s Program to Evaluate the Use of Blockchain to Protect Pharmaceutical Product Integrity

IBM, KPMG, Merck, Walmart Team Up for Drug Supply Chain Blockchain Pilot

Merck and Walmart Will Track Prescription Drugs on IBM Blockchain in FDA Pilot

The Dark Report: Four Insurers, Quest Developing Blockchain

Potentially Fatal Fungus Invades Hospitals and Public Is Not Informed

Clinical laboratories and microbiologists will want to be on the alert for this deadly infectious agent that has killed patients through blood infections

Healthcare continues to struggle with the issue of how much to disclose to the public when new and deadly infectious agents are identified in a limited number of patients. Timely disclosure of new pathogens is a matter of great concern to clinical laboratory scientists, microbiologists, and clinical pathologists because their laboratories get specimens from infected patients and they must correctly identify rare or emerging pathogens to help minimize the spread of disease.

This is why many medical laboratory professionals were surprised to see national news headlines recently about a particularly deadly new form of a pathogen. The Centers for Disease Control and Prevention (CDC) has been dealing with one particularly nasty example of Candida auris, or C. auris. This “superbug” fungus has been appearing in hospitals and healthcare clinics across the globe and it has killed people.

The news coverage of C. auris focused on two elements:

  • First, how the pathogen was recognized by such healthcare agencies as the CDC.
  • Second, why CDC and others did not issue a public alert to hospitals, physicians, and other caregivers once it was known that C. auris was responsible for the death of several patients.

Once C. auris takes hold, it can enter a patient’s bloodstream or wounds and cause life- threatening complications like sepsis. When hospitals rooms are not properly decontaminated, life-threatening hospital-acquired infections (HAIs), also known as nosocomial infections, can occur.

Incidences of HAIs have been on the rise in the past few years. Dark Daily has reported on this disturbing trend many times.

The New York Times (NYT) reported on one such HAI that had tragic consequences. A patient admitted to Mount Sinai Hospital in New York for abdominal surgery was later discovered to have contracted C. auris. He was immediately isolated and spent 90 days in the hospital before passing away. Tests showed that Candida auris was everywhere in his room.

“Everything was positive—the walls, the bed, the doors, the curtains, the phones, the sink, the whiteboard, the poles, the pump,” Scott Lorin, MD, President and Chief Operating Officer at Mount Sinai Brooklyn Hospital, told the NYT. “The mattress, the bed rails, the canister holes, the window shades, the ceiling, everything in the room was positive,” he said.

The hospital had to use special cleaning equipment to sterilize the room and even found it necessary to tear out some ceiling and floor tiles to annihilate the fungus, the NYT reported.

Media News Coverage of ‘Culture of Secrecy’ 

When this deadly fungus first emerged in America, it was not disclosed to the public for a lengthy period of time. Then, when details of deaths in hospitals due to the superbug went public, the national news media reacted but then went silent. Why?

The New York Times (NYT) covered the debate over public disclosure of outbreaks involving drug-resistant infections at healthcare facilities in “Culture of Secrecy Shields Hospitals with Outbreaks of Drug-Resistant Infections.”

In that article, the NYT states that “under its agreement with states, the CDC is barred from publicly identifying hospitals that are battling to contain the spread of dangerous pathogens.” So, the CDC is prevented from revealing to the public the names and locations of facilities that are dealing with C. auris. And state governments typically do not share that information either. 

The NYT article also states, “The CDC declined to comment, but in the past officials have said their approach to confidentiality is necessary to encourage the cooperation of hospitals and nursing homes, which might otherwise seek to conceal infectious outbreaks.”

And that, “Those pushing for increased transparency say they are up against powerful medical institutions eager to protect their reputations, as well as state health officials who also shield hospitals from public scrutiny.”

“Who’s speaking up for the baby that got the flu from the hospital worker or for the patient who got MRSA from a bedrail? The idea isn’t to embarrass or humiliate anyone, but if we don’t draw more attention to infectious disease outbreaks, nothing is going to change,” Arthur Caplan, PhD (above), told the NYT. Caplan is Drs. William F and Virginia Connolly Mitty Professor and founding head of the Division of Medical Ethics at NYU School of Medicine in New York City. (Photo copyright: NYU Langone Health.)

Common Yeast Infection or Killer Superbug? Both!

C. auris grows as a common yeast infection. However, it can be life threatening if it enters the bloodstream.

“The average person calls Candida infections yeast infections,” William Schaffner, MD, Professor and Chair, Department of Preventative Medicine at Vanderbilt University Medical Center, told Prevention. “However, Candida auris infections are much more serious than your standard yeast infection. They’re a variety of so-called superbugs [that] can complicate the therapy of very sick people.”

The CDC reports that, as of May 31, 2019, there have been a total of 685 cases of C. auris reported in the US. The majority of those cases occurred in Illinois (180), New Jersey (124), and New York (336). Twenty more cases were reported in Florida, and eight other states—California, Connecticut, Indiana, Maryland, Massachusetts, Oklahoma, Texas, and Virginia—each had less than 10 confirmed cases of C. auris.

The CDC states the infection seems to be most prominent among populations that have had extended stays in hospitals or nursing facilities. Patients who have had lines or tubes such as breathing tubes, feeding tubes, or central venous catheters entering their body, and those who have recently been given antibiotics or antifungal medications, seem to be the most vulnerable to contracting C. auris.

The fungus typically attacks people who are already sick or have weakened immune systems, which can make it challenging to diagnose, the CDC notes. C. auris infections are typically diagnosed with special clinical laboratory testing of blood specimens or other body fluids. Infections have been found in patients of all ages, from infants to the elderly.

Data from the CDC indicates that C. auris can cause bloodstream infections, wound infections, and ear infections. Common symptoms that indicate a person has Candida auris include fever, chills, weakness, low blood pressure, and general malaise that do not improve with antibiotics.

“A patient’s temperature may go up, their blood pressure can go down, and they have complications of a pre-existing illness because of Candida auris,” Schaffner told Prevention.

The CDC reports that more than one in three patients with invasive C. auris dies. Even though the mortality rates for Candida auris are high, it is unclear whether patients are dying from the infection or from their underlying illnesses. “Whatever the cause, having Candida auris doesn’t help a patient in any way,” Schaffner noted.

The CDC states that it and its public health partners are working hard to discover more about this fungus, and to devise ways to protect people from contracting it. Average healthy people probably don’t need to worry about becoming infected with Candida auris. However, individuals who are at high risk, and healthcare professionals, microbiologists, and pathologists, should be on the alert for this new superbug strain of fungus. 

—JP Schlingman

Related Information:

A Mysterious Infection, Spanning the Globe in a Climate of Secrecy

Culture of Secrecy Shields Hospitals with Outbreaks of Drug-Resistant Infections

Candida auris: A Drug-Resistant Germ That Spreads in Healthcare Facilities

A Deadly Superbug Fungus Called Candida auris Has Been Detected in 12 States—Here’s What You Need to Know

A Deadly Fungal Infection Called Candida auris Is Spreading across the Globe, and No One Knows How to Stop It

Study: Colonized Candida auris Patients Shed Fungus via Skin

The Deadly Yeast Infection You Must Know About

What You Need to Know Candida auris, a Dangerous Fungal Infection That’s on the Rise

With Candida auris, a Lack of Transparency Could Make Things Worse

Could Proximity of Toilets to Sinks in Medical Intensive Care Units Contribute to Hospital-Acquired Infections?

Clinical Laboratory Test for Alzheimer’s Disease Gets Ever Closer to Reality

Scientists worldwide engaged in research to develop a biomarker for dementia are predicting success, though some say additional research will be needed

Could a blood test for Alzheimer’s disease soon be on clinical laboratory test menus nationwide? Perhaps so. A recent Associated Press (AP) article that was picked up by NBC News and other healthcare publications reported that experimental test results presented during the Alzheimer’s Association International Conference (AAIC) in July suggest the Holy Grail of dementia tests—one where the specimen can be collected in a doctor’s office during a routine screening exam—may be close at hand.

The AP story noted that “half a dozen research groups gave new results on various experimental tests, including one that seems 88% accurate at indicating Alzheimer’s risk.” And Richard Hodes, MD, Director of the National Institute on Aging, told AP, “In the past year, we’ve seen a dramatic acceleration in progress [on Alzheimer’s tests]. This has happened at a pace that is far faster than any of us would have expected.”

This could be a boon for medical laboratories seeking way to contribute more value to patient care. Especially among Alzheimer’s patients, who account for as many as 70% of all dementia cases.

Plasma Biomarker for Predicting Alzheimer’s

One of the experimental blood tests presented at the AAIC involved a 2018 study into “the potential clinical utility of plasma biomarkers in predicting brain amyloid-β burden at an individual level. These plasma biomarkers also have cost-benefit and scalability advantages over current techniques, potentially enabling broader clinical access and efficient population screening,” the researchers stated an article they published in Nature.

Dark Daily reported on this study in “Researchers in Two Countries Develop Blood Tests That Detect Alzheimer’s Decades Before Symptoms Appear; Could Eventually Give Clinical Laboratories a Diagnostic Tool,” June 4, 2018. The test “measures abnormal versions of the protein [amyloid beta] that forms the plaques in the brain that are the hallmark of Alzheimer’s,” the AP story reported.

AP also reported that Japanese scientists at the AAIC presented results of a validation test conducted on 201 people who had either Alzheimer’s, other types of dementia, or little or no symptoms. They found that the test “correctly identified 92% of people who had Alzheimer’s and correctly ruled out 85% who did not have it, for an overall accuracy of 88%.”

Akinori Nakamura, MD, PhD, of the National Center for Geriatrics and Gerontology in Obu, Japan, was a member of the research team and first author of the research paper. He told the AP that the test results “closely matched those from the top tests used now—three types of brain scans and a mental assessment exam.”

Eric McDade, DO (above), Associate Professor of Neurology at Washington University in St. Louis, told Neurology Today, “The results reported here provide a relatively high level of confidence given that this is a relatively well characterized population with an amyloid PET scan to provide confirmation of a significant level of amyloid plaque burden in the brain.” Could this level of physician confidence lead to a clinical laboratory test based on the plasma biomarker? (Photo copyright: Washington University.)

Koichi Tanaka is a Japanese engineer who won the Nobel prize winner for chemistry. He heads the Koichi Tanaka Research Lab at Shimadzu Corp. (OTCMKTS:SHMZF) in Kyoto, Japan, and was on the team that developed the Amyloid beta biomarker test that was presented at AAIC. He told Bloomberg, “Our finding overturned the common belief that it wouldn’t be possible to estimate amyloid accumulation in the brain from blood. We’re now being chased by others, and the competition is intensifying.”

But Tanaka cautions that the test needs further study before it is ready for clinical use, and that for now “it belongs in the hands of drug developers and research laboratories,” Bloomberg reported.

Other Studies into Developing an Alzheimer’s Biomarker

Alzheimer’s is usually diagnosed after symptoms appear, such as memory loss. To arrive at their diagnoses, doctors often rely on medical history, brain imaging (MRI, CT), PET, and measurement of amyloid in spinal fluid.  

An article published on Alzforum, a website and news service dedicated to the research and treatment for Alzheimer’s and other related disorders, noted a study by King’s College London researchers who, using mass spectrometry, “found a panel of biomarkers that predicted with almost 90% accuracy whether cognitively normal people had a positive amyloid scan.”

Nicholas Ashton, PhD, neuroscientist and Wallenberg Postdoctoral Fellow at University of Gothenburg in Sweden, and first author of the King’s College study, explained that “Amyloid-burden and neurofilament light polypeptide (NFL) peptides were important in predicting Alzheimer’s, but alone they weren’t as predictable as when we combined them with novel proteins related to amyloid PET.”

The researchers published their study earlier this year in Science Advances. “Using an unbiased mass spectrometry approach, we have found and replicated with high accuracy, specificity, and sensitivity a plasma protein classifier reflecting amyloid-beta burden in a cognitively unimpaired cohort,” the researchers wrote.

Meanwhile, researchers at Washington University School of Medicine St. Louis, along with the German Center for Neurodegenerative Diseases, a member of the Helmholtz Association, stated in a news release that a blood test they developed works by detecting leaks of NFL before the onset of symptoms. When the protein is found in cerebrospinal fluid, it could be a sign that Alzheimer’s may develop, as well as point to other neurodegenerative conditions such as multiple sclerosis, brain injury, or stroke, the researchers stated.  

“This is something that would be easy to incorporate into a screening test in a neurology clinic,” Brian Gordon, PhD, Assistant Professor of Radiology at Washington University’s Mallinckrodt Institute of Radiology, and an author of the study, stated in the news release.

These parallel studies into screening for Alzheimer’s by researchers worldwide are intriguing. The favorable results suggest that someday there may be a screen for Alzheimer’s using a clinical laboratory blood test.

With Alzheimer’s affecting nearly six million Americans of all ages, such an assay would enable clinical laboratories to help many people.

—Donna Marie Pocius

Related Information:

Scientists Close in On Blood Test for Alzheimer’s

Advances in the Global Search for Blood Markers for Alzheimer’s Disease and Other Dementias

A Blood Test Can Predict Dementia. Trouble Is, There’s No Cure

Plasma Biomarker for Amyloid Correlates with Alzheimer’s Progression, Study Finds

High Performance Plasma Amyloid-β Biomarkers for Alzheimer’s Disease

Panel Blood Markers Signals Amyloid in Brain

A Plasma Protein Classifier for Predicting Amyloid Burden for Preclinical Alzheimer’s Disease

Blood Test Detects Alzheimer’s Damage Before Symptoms; Test Also May Identify Neurodegeneration in Other Brain Diseases

Blood-Brain Barrier Breakdown is an Early Biomarker of Human Cognitive Dysfunction

Researchers in Two Countries Develop Blood Tests That Detect Alzheimer’s Decades Before Symptoms Appear Could Eventually Give Clinical Laboratories A Diagnostic Tool

Artificial Intelligence Systems, Like IBM’s Watson, Continue to Underperform When Compared to Oncologists and Anatomic Pathologists

Though the field of oncology has some AI-driven tools, overall, physicians report the reality isn’t living up to the hype

Artificial intelligence (AI) has been heavily touted as the next big thing in healthcare for nearly a decade. Much ink has been devoted to the belief that AI would revolutionize how doctors treat patients. That it would bring about a new age of point-of-care clinical decision support tools and clinical laboratory diagnostic tests. And it would enable remote telemedicine to render distance between provider and patient inconsequential.

But nearly 10 years after IBM’s Watson defeated two human contestants on the game show Jeopardy, some experts believe AI has under-delivered on the promise of a brave new world in medicine, noted IEEE Spectrum, a website and magazine dedicated to applied sciences and engineering.

In the years since Watson’s victory on Jeopardy, IBM (NYSE:IBM) has announced almost 50 partnerships, collaborations, and projects intended to develop AI-enabled tools for medical purposes. Most of these projects did not bear fruit.

However, IBM’s most publicized medical partnerships revolved around the field of oncology and the expectation that Watson could analyze data and patients’ records and help oncologists devise personalized and effective cancer treatment plans. Success in helping physicians more accurately diagnosis different types of cancer would require anatomic pathologists to understand this new role for Watson and how the pathology profession should respond to it, strategically and tactically.

But Watson and other AI systems often struggled to understand the finer points of medical text. “The information that physicians extract from an article, that they use to change their care, may not be the major point of the study,” Mark Kris, MD, Medical Oncologist at Memorial Sloan Kettering Cancer Center, told IEEE Spectrum. “Watson’s thinking is based on statistics, so all it can do is gather statistics about main outcomes. But doctors don’t work that way.” 

Ultimately, IEEE Spectrum reported, “even today’s best AI struggles to make sense of complex medical information.”

“Reputationally, I think they’re in some trouble,” Robert Wachter, MD, Professor and Chair, Department of Medicine, University of California, San Francisco, told IEEE Spectrum. “They came in with marketing first, product second, and got everybody excited. Then the rubber hit the road. This is an incredibly hard set of problems, and IBM, by being first out, has demonstrated that for everyone else.”

“It’s a difficult task to inject AI into healthcare, and it’s a challenge. But we’re doing it,” John Kelly III, PhD, (above), Executive Vice President, IBM, who previously oversaw IBM’s Watson platform as Senior Vice President, Cognitive Solutions and IBM Research, told IEEE Spectrum. “We’re continuing to learn, so our offerings change as we learn.” (Photo copyright: IBM.)

Over Promises and Under Deliveries

In 2016, MD Anderson Cancer Center canceled a project with IBM Watson after spending $62 million on it, Becker’s Hospital Review reported. That project was supposed to use natural language processing (NLP) to develop personalized treatment plans for cancer patients by comparing databases of treatment options with patients’ electronic health records.

“We’re doing incredibly better with NLP than we were five years ago, yet we’re still incredibly worse than humans,” Yoshua Bengio, PhD, Professor of Computer Science at the University of Montreal, told IEEE Spectrum.

The researchers hoped that Watson would be able to examine variables in patient records and keep current on new information by scanning and interpreting articles about new discoveries and clinical trials. But Watson was unable to interpret the data as humans can.

IEEE Spectrum reported that “The realization that Watson couldn’t independently extract insights from breaking news in the medical literature was just the first strike. Researchers also found that it couldn’t mine information from patients’ electronic health records as they’d expected.”

Researchers Lack Confidence in Watson’s Results

In 2018, the team at MD Anderson published a paper in The Oncologist outlining their experiences with Watson and cancer care. They found that their Watson-powered tool, called Oncology Expert Advisor, had “variable success in extracting information from text documents in medical records. It had accuracy scores ranging from 90% to 96% when dealing with clear concepts like diagnosis, but scores of only 63% to 65% for time-dependent information like therapy timelines.”

A team of researchers at the University of Nebraska Medical Center (UNMC) have experimented with Watson for genomic analytics and breast cancer patients. After treating the patients, scientists identify mutations using their own tools, then enter that data into Watson, which can quickly pick out some of the mutations that have drug treatments available.

“But the unknown thing here is how good are the results,” Babu Guda, PhD, Professor and Chief Bioinformatics and Research Computing Officer at UNMC, told Gizmodo. “There is no way to validate what we’re getting from IBM is accurate unless we test the real patients in an experiment.” 

Guda added that IBM needs to publish the results of studies and tests performed on thousands of patients if they want scientists to have confidence in Watson tools.

“Otherwise it’s very difficult for researchers,” he said. “Without publications, we can’t trust anything.”

Computer Technology Evolving Faster than AI Can Utilize It

The inability of Watson to produce results for medical uses may be exacerbated by the fact that the cognitive computing technologies that were cutting edge back in 2011 aren’t as advanced today.

IEEE Spectrum noted that professionals in both computer science and medicine believe that AI has massive potential for improving and enhancing the field of medicine. To date, however, most of AI’s successes have occurred in controlled experiments with only a few AI-based medical tools being approved by regulators. IBM’s Watson has only had a few successful ventures and more research and testing is needed for Watson to prove its value to medical professionals.

“As a tool, Watson has extraordinary potential,” Kris told IEEE Spectrum. “I do hope that the people who have the brainpower and computer power stick with it. It’s a long haul, but it’s worth it.”

Meanwhile, the team at IBM Watson Health continues to forge ahead. In February 2019, Healthcare IT News interviewed Kyu Rhee, MD, Vice President and Chief Health Officer at IBM Corp. and IBM Watson Health. He outlined the directions IBM Watson Health would emphasize at the upcoming annual meeting of the Healthcare Information and Management Systems Society (HIMSS).

IBM Watson Health is “using our presence at HIMSS19 this year to formally unveil the work we’ve been doing over the past year to integrate AI technology and smart, user-friendly analytics into the provider workflow, with a particular focus on real-world solutions for providers to start tackling these types of challenges head-on,” stated Rhee. “We will tackle these challenges by focusing our offerings in three core areas. First, is management decision support. These are the back-office capabilities that improve operational decisions.”

Clinical laboratory leaders and anatomic pathologists may or may not agree about how Watson is able to support clinical care initiatives. But it’s important to note that, though AI’s progress toward its predicted potential has been slow, it continues nonetheless and is worth watching.

—JP Schlingman

Related Information:

How IBM Watson Overpromised and Underdelivered on AI Health Care

Why Everyone is Hating on IBM Watson – Including the People Who Helped Make It

Memorial Sloan Kettering Trains IBM Watson to Help Doctors Make Better Cancer Treatment Choices

4 Reasons MD Anderson Put IBM Watson On Hold

IBM Watson Health’s Chief Health Officer Talks Healthcare Challenges and AI

Applying Artificial Intelligence to Address the Knowledge Gaps in Cancer Care

After Taking on Jeopardy Contestants, IBM’s Watson Supercomputer Might Be a Resource for Pathologists

Will IBM’s ‘Watson on Oncology’ Give Oncologists and Pathologists a Useful Tool for Diagnosing and Treating Various Cancers?

IBM’s Watson Not Living Up to Hype, Wall Street Journal and Other Media Report; ‘Dr. Watson’ Has Yet to Show It Can Improve Patient Outcomes or Accurately Diagnose Cancer

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