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CDC Issues Warning on Candida Auris, a Highly Drug Resistant and Dangerous Yeast Infection

CDC advises clinical laboratories and microbiologists encountering C. auris to follow their own protocols before adopting federal agency guidelines

In July, the Centers for Disease Control and Prevention (CDC) warned healthcare facilities and clinical laboratories to be on the alert for Candida auris (C. auris) infections in their patients. An outbreak of the drug resistant and potentially deadly fungus had appeared in two Dallas hospitals and a Washington D.C. nursing home.

Since those outbreaks, researchers have studied with urgency the “superbug’s” emergence in various types of healthcare facilities around the nation, not just hospitals. Their goal was to discover how it was successfully identified and contained.

One such recently released study involved researchers from the Orange County Health Department (OCHD) working with the California Department of Public Health and the CDC to track C. auris in long-term acute care hospitals (LTACHs) and ventilator-capable skilled-nursing facilities (vSNFs), Medscape reported.

The researchers published their findings in Annals of Internal Medicine, titled, “Rapid Assessment and Containment of Candida auris Transmission in Post-acute Care Settings—Orange County, California, 2019.”

“Seeing what was happening in New York, New Jersey, and Illinois [was] pretty alarming for a lot of the health officials in California [who] know that LTACHs are high-risk facilities because they take care of [very] sick people. Some of those people are there for a very long time,” the study’s lead author Ellora Karmarkar, MD, MSc, told Medscape. Karmarkar is an infectious disease fellow with the University of Washington and formerly an epidemic intelligence service officer with the CDC.

“One of the challenges was that people were so focused on COVID that they forgot about the MDROs (multi-drug resistant organisms] … Some of the things that we recommend to help control Candida auris are also excellent practices for every other organism including COVID care,” she added.

According to Medscape, “The OCHD researchers screened LTACH and vSNF patients with composite cultures from the axilla-groin or nasal swabs. Screening was undertaken because 5%–10% of colonized patients later develop invasive infections, and 30%–60% die.

Medscape also reported that the first bloodstream infection was detected in May 2019, and that, according to the Annals of Internal Medicine study, as of January 1, 2020, of 182 patients:

  • 22 (12%) died within 30 days of C. auris identification,
  • 47 (26%) died within 90 days,
  • One of 47 deaths was attributed to C. auris,
  • Whole-genome sequencing showed that the isolates were all closely related in clade III.

“This is really the first time we’ve seen clustering of resistance in which patients seemed to be getting the infections from each other,” Meghan Lyman, MD, Medical Officer in the Mycotic Diseases Branch of the CDC, told Fox News.

Candida auris graphic

The graphic above illustrates how Candida auris is “spanning the globe,” The New York Times reported. Clinical laboratories that encounter this potentially deadly fungus are advised to contact the CDC immediately for guidance and to take proactive steps to prepare for the “superbug’s” arrival. (Graphic copyright: The Scottish Sun.)

Be More Proactive than Reactive in Identifying C. Auris, CDC Says

C. auris is a type of yeast infection that can enter the bloodstream, spread throughout the body, and cause serious complications. People who appear to have the highest risk of contracting the infection are those:

  • Who have had a lengthy stay in a healthcare facility,
  • Individuals connected to a central venous catheter or other medical tubes, such as breathing or feeding tubes, or
  • Have previously received antibiotics or antifungal medications.

The CDC is concerned about C. auris for three primary reasons:

  • It tends to be resistant to the antifungal drugs that are commonly used to treat Candida infections.
  • It can be difficult to identify via standard laboratory testing and is easily misidentified in labs without specific technology.
  • It can quickly lead to outbreaks in healthcare settings.

“With all this spread that we’ve been seeing across the country we’re really encouraging health departments and facilities to be more proactive instead of reactive to identifying Candida auris in general,” Lyman told STAT. “Because we’ve found that controlling the situation and containing spread is really easiest when it’s identified early before there’s widespread transmission.”

Dan Diekema, MD

There continues to be concerns over this highly drug-resistant infection among hospital physicians and medical laboratories. “Acute care hospitals really ought to be moving toward doing species identification of Candida from nonsterile sites if they really want to have a better chance of detecting this early,” Dan Diekema, MD (above), an epidemiologist and clinical microbiologist at the University of Iowa, told Medscape. (Photo copyright: University of Iowa.)

Candia Auris versus Other Candida Infections

C. auris can cause dangerous infections in the bloodstream and spread to the central nervous system, kidneys, liver, spleen, bones, muscles, and joints. It spreads mostly in long-term healthcare facilities among patients with other medical conditions.

The symptoms of having a Candida auris infection include:

  • Fever
  • Chills
  • Pain
  • Redness and swelling
  • Fluid drainage (if an incision or wound is present)
  • General feeling of tiredness and malaise

C. auris infections are typically diagnosed via cultures of blood or other bodily fluids, but they are difficult to distinguish from more common types of Candida infections, and special clinical laboratory tests are needed to definitively diagnose C. auris.

Whole-genome Sequencing of C. Auris and Drug Resistance

The CDC conducted whole-genome sequencing of C. auris specimens gathered in Asia, Africa, and South America and discovered four different strains of the potentially life-threatening Candida species. All four detected strains have been found in the United States.

There are only three classes of antifungal drugs used to treat Candida auris infections:

However, 85% of the infections in the US have proven to be resistant to azoles and 38% are resistant to polyenes. Patients respond well to echinocandins, but more effective therapies are needed especially as some isolates may become resistant while a patient is on drug therapy, STAT reported.

“Even while it might be susceptible upfront, after a week or two of therapy, we may find that the patient has an infection now caused by an isolate of the same Candida auris that has become resistant to the echinocandins and we are really left with nothing else,” Jeffrey Rybak, PhD, PharmD, Instructor, Department of Pharmaceutical Sciences, St. Jude Children’s Research Hospital, told Infection Control Today.

Although relatively rare, C. auris infections are on the rise. The good news is that there may be further pharmaceutical help available soon. New antifungal agents, such as Ibrexafungerp (Brexafemme) show promise in fighting C. auris infections, but more research is needed to prove their efficacy.

What Should Clinical Laboratories Do?

The CDC stresses that clinical laboratories and microbiologists working with known or suspected cases of Candida auris should first adhere to their own safety procedures. The CDC issued guidelines, but they are not meant to supersede the policies of individual labs.

The CDC also recommends that healthcare facilities and clinical laboratories that suspect they have a patient with a Candida auris infection immediately contact the CDC and state or local public health authorities for guidance.  

JP Schlingman

Related Information

U.S. Sees First Cases of Dangerous Fungus Resistant to all Drugs in Untreated People

‘Superbug’ Fungus Spread in Two Cities, Health Officials Say           

CDC: Candida auris

CDC: Drug-resistant Candida auris   

CDC Reports Two Outbreaks of Pan-resistant Candida auris

Notes from the Field: Transmission of Pan-Resistant and Echinocandin-Resistant Candida auris in Health Care Facilities―Texas and the District of Columbia, January–April 2021

Drugs in Development Might Help Fight Deadly Candida Auris

During Pandemic, Clinical Laboratories Should Be Alert for Drug Resistant Infections That Pose High Risk to COVID-19 Patients

Potentially Fatal Fungus Invades Hospitals and Public Is Not Informed

Canada’s Early Response to COVID-19 Garnered Praise, But Critical Shortages of Clinical Lab Tests and Delays in Test Results Brought Criticism of the Government’s Actions. Sound Familiar?

Though coronavirus infections were detected nearly simultaneously in both Canada and the US, total cases and total deaths vary dramatically leading experts to question how differences in healthcare systems might have contributed

Can clinical laboratories in the United States learn from Canada’s response to the COVID-19 pandemic? While our northern neighbor won praise for its early response to the coronavirus, since then Canada has faced criticism over a lack of access to SARS-CoV-2 testing and long wait times for test results—criticism levied at the United States’ response to the outbreak as well.

In “Canada Shows How Easy Virus Testing Can Be,” Foreign Policy reported that Canada was more prepared to mount a successful response to COVID-19 because it systematically improved its pandemic-response preparedness and testing capacity after the 2003 SARS coronavirus (SARS-CoV-1) outbreak.

“Provincial laboratories put the infrastructure in place that would allow them to run their own testing and validation without help from the federal government,” Foreign Policy wrote. “At the same time, the federally run National Microbiology Laboratory in Winnipeg expanded its own capacity to support those efforts.”

However, Canada’s pandemic response has not been criticism free. In “Health Minister Says Test Result Wait Times ‘Not Acceptable’ As Ontario Confirms 25 New COVID-19 Cases,” CBC News reported in late March about COVID-19 testing shortages and four-day wait times for test results that were “not acceptable,” particularly in Ontario, where people with mild symptoms were being refused testing and sent home unless they worked in high-risk settings.

In “Why It’s So Difficult to Get Tested for COVID-19 in Canada,” CBC News suggested that Canada’s test rationing was due to a laboratory-supply shortage, a problem which The New York Timesreports still has not been overcome in the US more than six months into the pandemic.

Government Bureaucracy’s Effect on Response to COVID-19

In “Canada’s Coronavirus Response Has Not Been Perfect. But It’s Done Far Better than the US,” The Washington Post reported that the initial exposure to the virus by the US and Canada was similar. Both the US and Canada have extensive ties to Europe and China, resulting in the two countries identifying their first cases of COVID-19 within a week of one another in January. Since then, however, the progression of the disease diverged dramatically in the two nations.

To date, the US has experienced 7,361,611 total cases with 209,808 total deaths, placing it in the number one spot globally on Worldometers’ COVID-19 tracking site. By contrast, Canada is in 26th place, with 155,301 total cases and 9,278 total deaths. However, to date the US has conducted 105,401,706 total clinical laboratory tests, as opposed to Canada’s 7,220,108 total tests. This might account for the disparity in total cases, but what accounts for the huge difference in total US deaths due to COVID-19 compared to Canada?

A Fraser Institute blog post authored by Steven Globerman, PhD, Resident Scholar and Addington Chair in Measurement at the Institute and Professor Emeritus at Western Washington University, titled, “US COVID Experience Highlights Risks of Centralized Management of Healthcare,” blamed the US’ “top-down, centralized approach to testing” for the “testing fiasco” that marked the US’ initial slow response to the pandemic. Globerman maintained the Centers for Disease Control and Prevention’s insistence on producing its own COVID-19 diagnostic test, rather than using a proven German-produced test, was the first of several missteps by the US.

Steven Globerman, PhD
“While there has been much criticism of the decentralized private insurance industry in the US, the major shortcomings in testing that characterize the US experience during the current pandemic seem to be the result of the government healthcare bureaucracy,” wrote Steven Globerman, PhD, (above), Resident Scholar and Addington Chair in Measurement at the Fraser Institute and Professor Emeritus at Western Washington University. (Photo copyright: Fraser Institute.)

Globerman also noted the problems were compounded by the US government’s low initial Medicare payments to private laboratories for COVID-19 tests. “Medicare is reputed to have paid about half the price it pays for a flu test, even though the coronavirus test is substantially more expensive to produce. The price forced labs to take losses on the test, blocking many labs from scaling up production to expand the nation’s testing capacity.

“Only after major lab organizations made public pleas for increased Medicare reimbursement, and long backlogs emerged for testing and reporting test results, did Medicare agree to double its payments for coronavirus tests,” Globerman wrote.

Could National Differences in Healthcare Systems Be to Blame for Disparate COVID-19 Outcomes?

In “Canada Succeeded on Coronavirus Where America Failed. Why?” Canadian public health experts told Vox differences in the two countries’ political leadership, public health funding, and healthcare systems are to blame for the US experiencing a worse coronavirus outbreak than Canada.

Is that true? Sally C. Pipes, CEO, and Thomas W. Smith Fellow in Health Care Policy at the Pacific Research Institute, a former resident of Canada and an ardent critic of single-payer healthcare, argued that Canada’s healthcare system is plagued by long waits for elective procedures, equipment shortages, and limited access to cutting-edge drugs and therapies.

In “The Canadian Health-Care Scare,” Pipes wrote, “Our northern neighbors wait months for routine care and lack access to the latest life-saving medications and technology. Importing this system would lead to widespread misery,” adding, “Is a six-month wait for a knee replacement—the median in Canada last year—reasonable, when it keeps someone in pain and unable to work? One study puts the total cost of waiting for joint-replacement surgery after taking into account lost wages and additional tests and scans at almost $20,000. It’s no wonder that more than 323,000 Canadians left the country to seek care abroad in 2017.”

A Fraser Institute study of wait times in Canada for medically-necessary treatments underscores Pipes’ claims. According to the study, the median wait time—from general practitioner referral to treatment—across 12 medical specialties was 20.9 weeks in 2019, the second highest recorded by the Institute. If this is the case, how did Canada earn praise for its early COVID-19 response?

It’s unclear what lessons American clinical laboratories can glean from Canada’s response to COVID-19. Nevertheless, lab managers should closely watch their counterparts in other nations around the world. The coronavirus does not respect borders or care about disparities in healthcare systems.

—Andrea Downing Peck

Related Information:

The Canadian Health-Care Scare

Waiting Your Turn: Waiting Times for Healthcare in Canada, 2019 Report

Worldometers COVID-19 Coronavirus Pandemic Tracking

Canada Succeeded on Coronavirus Where America Failed. Why?

Coronavirus Test Results Are Still Delayed

U.S. Doctor in Canada: Medicare for All would Have Made America’s COVID Response Much Better

Canada’s Coronavirus Response Has Not Been Perfect. But It’s Done Far Better than the U.S.

Why It’s so Difficult to Get Tested for COVID-19 in Canada

Health Minister Says Test Result Wait Times ‘Not Acceptable’ as Ontario Confirms 25 New COVID-19 Cases

Canada Shows How Easy Virus Testing Can Be

Multiple Studies Raise Questions About Reliability of Clinical Laboratory COVID-19 Diagnostic Tests

In the absence of a “gold standard,” researchers are finding a high frequency of false negatives among SARS-CoV-2 RT-PCR tests

Serology tests designed to detect antibodies to the SARS-CoV-2 coronavirus that causes the COVID-19 illness have been dogged by well-publicized questions about accuracy. However, researchers also are raising concerns about the accuracy of molecular diagnostics which claim to detect the actual presence of the coronavirus itself.

“Diagnostic tests, typically involving a nasopharyngeal swab, can be inaccurate in two ways,” said Steven Woloshin, MD, MS, in a news release announcing a new report that “examines challenges and implications of false-negative COVID-19 tests.” Woloshin is an internist, a professor at Dartmouth Institute, and co-director of the Geisel School of Medicine at Dartmouth.

“A false-positive result mistakenly labels a person infected, with consequences including unnecessary quarantine and contact tracing,” he stated in the news release. “False-negative results are far more consequential, because infected persons who might be asymptomatic may not be isolated and can infect others.”

Woloshin led a team of Dartmouth researchers who analyzed two studies from Wuhan, China, and a literature review by researchers in Europe and South America that indicated diagnostic tests for COVID-19 are frequently generating false negatives. The team published their results in the June 5 New England Journal of Medicine (NEJM).

For example, one research team in Wuhan collected samples from 213 hospitalized COVID-19 patients and found that an approved RT-PCR test produced false negatives in 11% of sputum samples, 27% of nasal samples, and 40% of throat samples. Their research was published on the medRxiv preprint server and has not been peer-reviewed.

The literature review Woloshin’s team studied was also published on medRxiv, titled, “False-Negative Results of Initial Rt-PCR Assays for COVID-19: A Systematic Review.” It indicated that the rate of false negatives could be as high as 29%. The authors of the review looked at five studies that had enrolled a total of 957 patients. “The collected evidence has several limitations, including risk of bias issues, high heterogeneity, and concerns about its applicability,” they wrote. “Nonetheless, our findings reinforce the need for repeated testing in patients with suspicion of SARS-Cov-2 infection.”

Another literature review, published in the Annals of Internal Medicine, titled, “Variation in False-Negative Rate of Reverse Transcriptase Polymerase Chain Reaction–Based SARS-CoV-2 Tests by Time Since Exposure,” estimated the probability of false negatives in RT-PCR tests at varying intervals from the time of exposure and symptom onset. For example, the authors found that the median false-negative rate was 38% if a test was performed on the day of symptom onset, versus 20% three days after onset. Their analysis was based on seven studies, five of which were peer-reviewed, with a total of 1330 test samples.

Doctors also are seeing anecdotal evidence of false negatives. For example, clinicians at UC San Diego Health medical center treated a patient with obvious symptoms of COVID-19, but two tests performed on throat samples were negative. However, a third test, using a sample from a bronchial wash, identified the virus, reported Medscape.

The lesson for clinicians is that they can’t rely solely on test results but must also consider their own observations of the patient, Joshua Metlay, MD, PhD, of Massachusetts General Hospital told Medscape.

Sensitivity and Specificity of COVID-19 Clinical Laboratory Tests

The key measures of test accuracy are sensitivity, which refers to the ability to detect the presence of the virus, and specificity, the ability to determine that the targeted pathogen is not present. “So, a sensitive test is less likely to provide a false-negative result and a specific test is less likely to provide a false-positive result,” wrote Kirsten Meek, PhD, medical writer and editor, in an article for ARUP Laboratories.

“Analytic” sensitivity and specificity “represent the accuracy of a test under ideal conditions in which specimens have been collected from patients with either high viral loads or a complete absence of exposure,” she wrote. However, “sensitivity and specificity under real-world conditions, in which patients are more variable and specimen collection may not be ideal, can often be lower than reported numbers.”

In a statement defending its ID Now molecular point-of-care test, which came under scrutiny during a study of COVID-19 molecular tests by NYU Langone Health, Northwell Health, and Cleveland Clinic, according to MedTech Dive, Abbott Laboratories blamed improper sample collection and handling for highly-publicized false negatives produced by its rapid test. An FDA issued alert about the test on May 14 noted that Abbott had agreed to conduct post-market studies to identify the cause of the false negatives and suggest remedial actions.

Issues with Emergency Use Authorizations

In their NEJM analysis, Woloshin et al point to issues with the FDA’s process for issuing Emergency Use Authorizations (EUAs). For example, they noted variations in how manufacturers are conducting clinical evaluations to determine test performance. “The FDA prefers the use of ‘natural clinical specimens’ but has permitted the use of ‘contrived specimens’ produced by adding viral RNA or inactivated virus to leftover clinical material,” they wrote.

When evaluating clinical performance, manufacturers ordinarily conduct an index test of patients and compare the results with reference-standard test, according to the Dartmouth researchers. For people showing symptoms, the reference standard should be a clinical diagnosis performed by an independent adjudication panel. However, they wrote, “it is unclear whether the sensitivity of any FDA-authorized commercial test has been assessed in this way.” Additionally, a reference standard for determining sensitivity in asymptomatic people “is an unsolved problem that needs urgent attention to increase confidence in test results for contact-tracing or screening purposes.”

Stephen Rawlings, MD, PhD
“To truly determine false negatives, you need a gold standard test, which is essentially as close to perfect as we can get,” Stephen Rawlings, MD, PhD, (above), a resident physician of internal medicine and infectious diseases fellow at UC San Diego’s Center for AIDS Research (CFAR), who has been working on SARS-CoV-2 test validation since March. “But there just isn’t one yet for coronavirus,” he told Medscape. (Photo copyright: University of California, San Diego.)

In a perspective for Mayo Clinic Proceedings, Colin P. West, MD, PhD; Victor M. Montori, MD, MSc; and Priya Sampathkumar, MD, offered four recommendations for addressing concerns about testing accuracy:

  • Continued adherence to current measures, such as physical distancing and surface disinfection.
  • Development of highly sensitive and specific tests or combinations of tests to minimize the risk of false-negative results and ongoing transmission based on a false sense of security.
  • Improved RT-PCR tests and serological assays.
  • Development and communication of clear risk-stratified protocols for management of negative COVID-19 test results.

“These protocols must evolve as diagnostic test, transmission, and outcome statistics become more available,” they wrote.

Meanwhile, clinical laboratories remain somewhat on their own at selecting which COVID-19 molecular and serology tests they want to purchase and run in their labs. Complicating such decisions is the fact that many of the nation’s most reputable in vitro diagnostics manufacturers cannot produce enough of their COVID-19 tests to meet demand.

Consequently, when looking to purchase tests for SARS-CoV-2, smaller medical laboratory organizations find themselves evaluating COVID-19 kits developed by little-known or even brand-new companies.

—Stephen Beale

Related Information:

New Report Examines Challenges and Implications of False-Negative COVID-19 Tests

Questions about COVID-19 Test Accuracy Raised Across the Testing Spectrum

COVID-19 Test Results: Don’t Discount Clinical Intuition

FDA Provides New Tool to Aid Development and Evaluation of Diagnostic Tests That Detect SARS-CoV-2 Infection

EUA Authorized Serology Test Performance

Emergency Use Authorization (EUA) Information and List of All Current EUAs 

Coronavirus (COVID-19) Update: FDA Provides Promised Transparency for Antibody Tests

Understanding Medical Tests: Sensitivity, Specificity, and Positive Predictive Value

Webinar Part 1: Quality Issues Your Clinical Laboratory Should Know Before You Buy or Select COVID-19 Serology Tests

Webinar Part 2: Achieving High Confidence Levels in the Quality and Accuracy of Your Clinical Lab’s Chosen COVID-19 Serology Tests, featuring James Westgard, PhD

Regenstrief Institute Finds Fecal Immunochemical Test May Be as Effective as Colonoscopy at Detecting Colorectal Cancers

Doctors may begin ordering FITs in greater numbers, increasing the demand on clinical laboratories to process these home tests

All clinical laboratory managers and pathologists know that timely screening for colon cancer is an effective way to detect cancer early, when it is easiest to treat. But, invasive diagnostic approaches such as colonoscopies are not popular with consumers. Now comes news of a large-scale study that indicates the non-invasive fecal immunochemical test (FIT) can be as effective as a colonoscopy when screening for colon cancer.

FITs performed annually may be as effective as colonoscopies at detecting colorectal cancer (CRC) for those at average risk of developing the disease. That’s the conclusion of a study conducted at the Regenstrief Institute, a private, non-profit research organization affiliated with the Indiana University School of Medicine in Indianapolis, Ind.

The researchers published their findings in the Annals of Internal Medicine (AIM), a journal published by the American College of Physicians (ACP). The team reviewed data from 31 previous studies. They then analyzed the test results from more than 120,000 average-risk patients who took a FIT and then had a colonoscopy. After comparing the results between the two tests, the researchers concluded that the FIT is a sufficient screening tool for colon cancer.

FIT is Easy, Safe, and Inexpensive

As a medical laboratory test, the FIT is low risk, non-invasive, and inexpensive. In addition, the FIT can detect most cancers in the first application, according to the Regenstrief Institute researchers. They recommend that the FIT be performed on an annual basis for people at average risk for getting colorectal cancers.

“This non-invasive test for colon cancer screening is available for average risk people,” Imperiale told NBC News. “They should discuss with their providers whether it is appropriate for them.”

FIT is performed in the privacy of the patient’s home. To use the test, an individual collects a bowel specimen in a receptacle provided in a FIT kit. They then send the specimen to a clinical laboratory for evaluation. The FIT requires no special preparations and medicines and food do not interfere with the test results.

Thomas Imperiale, MD (above), is a Lawrence Lumeng Professor of Gastroenterology and Hepatology at Indiana University School of Medicine, and a research scientist at the Regenstrief Institute. He led a study which concluded that FITs are as effective as colonoscopies at detecting cancer in average risk patient populations. Should these conclusions become widely accepted, doctors may begin ordering FITs in greater numbers, increasing the demand on clinical laboratories that process the tests. (Photo copyright: Indiana University School of Medicine.)

‘A Preventative Health Success Story’

The FIT can be calibrated to different sensitivities at the lab when determining results. Imperiale and his team found that 95% of cancers were detected when the FIT was set to a higher sensitivity, however, that setting resulted in 10% false positives. At lower sensitivity the FIT produced fewer false positives (5%), but also caught fewer cancers (75%). However, when the FIT was performed every year, the cancer detection rate was similar at both sensitivities over a two-year period.

“FIT is an excellent option for colon cancer screening only if it is performed consistently on a yearly basis,” Felice Schnoll-Sussman, MD, told NBC News. Sussman is a gastroenterologist and Professor of Clinical Medicine at Weill Cornell Medicine. “Colon cancer screening and its impact on decreasing rates of colon cancer is a preventative health success story, although we have a way to go to increase rates to our previous desired goal of 80% screened in the US by 2018.”

The FIT looks for hidden blood in the stool by detecting protein hemoglobin found in red blood cells. A normal result indicates that FIT did not detect any blood in the stool and the test should be repeated annually. If the FIT comes back positive for blood in the stool, other tests, such as a sigmoidoscopy or colonoscopy should be performed. Cancers in the colon may not always bleed and the FIT only detects blood from the lower intestines.

Patients are Skipping the Colonoscopy

Approximately 35% of individuals who should be receiving colonoscopies do not undergo the test, NBC News noted. The American Cancer Society (ACS) lists the top five reasons people don’t get screened for colorectal cancer are that they:

  • fear the test will be difficult or painful;
  • have no family history of the disease and feel testing is unnecessary;
  • have no symptoms and think screening is only for those with symptoms;
  • are concerned about the costs associated with screening; and
  • they are concerned about the complexities of taking the tests, including taking time off from work, transportation after the procedure, and high out-of-pocket expenses.

“Colorectal cancer screening is one of the best opportunities to prevent cancer or diagnose it early, when it’s most treatable,” Richard Wender, MD, Chief Cancer Control Officer for the ACS stated in a press release. “Despite this compelling reason to be screened, many people either have never had a colorectal cancer screening test or are not up to date with screening.”

Colorectal cancer is the third most common cancer diagnosed in both men and women in the United States. The ACS estimates there will be 101,420 new cases of colon cancer and 44,180 new cases of rectal cancer diagnosed this year. The disease is expected to be responsible for approximately 51,020 deaths in 2019.

New cases of the disease have been steadily decreasing over the past few decades in most age populations, primarily due to early screening. However, the overall death rate among people younger than age 55 has increased 1% per year between 2007 and 2016. The ACS estimates there are now more than one million colorectal cancer survivors living in the US.

The ACS recommends that average-risk individuals start regular colorectal cancer screenings at age 45. The five-year survival rate for colon cancer patients is 90% when there is no sign that the cancer has spread outside the colon.

Clinical laboratory professionals may find it unpleasant to test FIT specimens. Opening the specimen containers and extracting the samples can be messy and malodorous. However, FITs are essential, critical tests that can save many lives.

—JP Schlingman

Related Information:

Annual Stool Test May Be as Effective as Colonoscopy, Study Finds

Top Five Reasons People Don’t Get Screened for Colorectal Cancer

About Colorectal Cancer

Performance Characteristics of Fecal Immunochemical Tests for Colorectal Cancer and Advanced Adenomatous Polyps: A Systematic Review and Meta-analysis

Recent Study Looks at How Consumers Use Wearables That Generate Biometric data and Whether Such Data Might Be Valuable for Physicians and Medical Laboratories

Precision medicine programs can benefit from wearable usage data; however, little information has been collected on personalities and behaviors of the device users

Wearables medical devices have the potential to monitor some of the same biomarkers used in medical laboratory tests today. In addition, these mobile technologies can make it possible for clinical laboratories to monitor patients in real time, as well as allow labs to incorporate such into a patient’s historical record of lab test results.

The trend toward personalized medicine (aka, Precision Medicine) is increasing, with many payment programs based on it. Thus, monitoring and correcting activities that cause chronic disease, or work against treatments, is becoming standard procedure for forward-thinking, technically proficient doctors and hospitals. But are patients onboard with all of it?

Activity Trackers for Monitoring Patient Behavior

With the popularity of activity trackers on the rise, researchers are examining their usage patterns to determine how the devices are being utilized, their target market, and ways to encourage sustained use of the gadgets.

A recent article published in Annals of Internal Medicine provided insight regarding who is using this type of wearable device, how activity trackers are being employed, and the length of time consumers will maintain their usage.

The research was spearheaded by Mitesh Patel, MD, Assistant Professor of Medicine and Health Care Management, Perelman School of Medicine and the Wharton School, University of Pennsylvania. He believes this is the largest study of its kind to evaluate the usage of wearable fitness trackers.

“Many people are excited by the potential of using activity trackers to monitor healthy behaviors, but there is very little evidence on who is using them and whether or not use is sustained over time,” Patel stated in a Penn Medicine news release. “We found that, though use grew over time, it really varied depending on individual characteristics like age and income. We also found that once someone started using an activity tracker, sustained use at six months was high at 80%.”

Patel is also Director of the Penn Medicine Nudge Unit, a behavioral design team that is studying the impact that nudges or small interventions may have on healthcare. The team is examining ways in which nudges can influence choices, and also direct medical professionals and patients toward optimal decisions to improve healthcare delivery and results. (Photo copyright: University of Pennsylvania.)

Gaming the Study Improves Usage of Test Devices

To perform the study, 4.4 million members of a national wellness program were invited to take part in data collection. Approximately 55,000 of those individuals actually participated in the study, which involved downloading an app to record pertinent information. Researchers tracked and interpreted the data during a two-year period in 2014 and 2015.

The information analyzed included:

  • When participants initially activated their tracker;
  • How often the device was utilized;
  • The average number of steps taken per day; and,
  • Sociodemographic characteristics.

The results of the study were not entirely unexpected, but there were surprises:

  • 80% of the people who initially activated the devices were still using them after six months;
  • Only 0.2% of the invited individuals used the devices in the first year;
  • However, that number increased to 1.2% during the second year.

The usage of wearable activity trackers was nearly double among younger people than it was for older individuals. In addition, people from households with an annual income of less than $50,000 used the gadgets at lower rates than those at higher income levels.

A mere 0.1% of the potential participants were over 65-years old. However, 90% of individuals in this age group were still using the devices six months after initial activation.

The authors of the study stated that adding game elements, such as points, levels, badges and financial incentives may have played a role in the sustained use of the activity trackers.

Gamification and financial incentives are commonly used within wellness programs, but their impact has not been well studied,” Patel stated in the news release. “Our findings provide initial evidence suggesting that these types of engagement strategies may show promise for keeping sustained use high. However, more studies are needed to determine the best way to combine these types of engagement strategies with activity trackers to improve health outcomes.”

Most Commonly Used Mobile Activity Tracking Devices

There were 60 different types of wearable activity trackers that could be used by participants for the study. Seventy-six percent of those participants elected to use the FitBit activity tracker. This mobile healthcare device is worn on the wrist like a watch. It monitors activity, exercise, food, weight, and sleep to provide consumers with real-time data about their activities.

The data collected by the device is sent automatically and wirelessly to the user’s phone or computer. Individuals then can use the FitBit dashboard to view their progress through online charts and graphs. The dashboard also offers progress notifications to the consumer and gives achievement badges when established goals have been reached.

The second most common activity trackers used were Apple devices, such as Apple Watches, which were chosen by 9% of the participants.

Biometric data on patients’ behavior and activities that is collected and transmitted from mobile devices has swiftly become critical data doctors use in precision medicine diagnoses and treatments. Clinical laboratories will likely be including biomarker data taken by these devices in their testing and procedures in the future. The only question is how quickly the data generated by such devices becomes acceptable to add to a patient’s permanent health record.

—JP Schlingman

Related Information:

New Wellness Study Shows Just How Sticky Wearables Can Be, Even Among Seniors

Penn Study Shows 80% of Activity Tracker Users Stick with the Devices for at Least Six Months

Game Time: To Increase Exercise, Study Shows Gaming Strategies and a Buddy Are Key

When Push Comes to Nudge

Improvements to Fitness Wearables Help Stream Data from Consumers’ Homes to EHRs and Clinical Pathology Laboratories

Apple May Be Developing Mobile Device Technology to Monitor User’s Health and Transmit Data in Real Time