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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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

UCLA’s Ozcan Labs Develops Portable Smartphone DNA Detection System That Performs as well as Clinical Laboratory Testing

Mobile point-of-care (POC) smartphone-based nucleic acid assay allows for quick turn arounds and accurate information in any healthcare setting, including resource limited and remote environments 

DNA detection might soon be accomplished with the use of a smartphone. That’s the goal of a research effort at the University of California Los Angeles (UCLA). If this effort succeeds, it would give medical laboratories a new tool to use in genetic testing.

Clinical laboratory equipment is becoming more effective even as it shrinks in size and cost. One such device has been developed by Ozcan Laboratory Group, headed by UCLA professor Aydogan Ozcan, PhD. It is a portable, smartphone-based mobile lab with sensitivity and reliability on par with large-scale medical laboratory-based equipment.

Ozcan Lab’s portable DNA detection system, according to a UCLA press release, “leverages the sensors and optics of cellphones” and adapts them to read and report the presence of DNA molecules. The sensor uses a new detector dye mixture and reportedly produces a signal that is 10 to 20 times brighter than previous detector dye outputs.

This new system improves upon the optical detection abilities of current point-of-care nucleic acid tests (POCTs) and, according to a study published in the American Chemical Society’s ACS Nano, the device is able to “retain the same robust standards of benchtop lab-based tests.”

Go Anywhere Technology Improves POC Testing

Nucleic acid detecting assays are crucial tools anatomic pathologists use to identify pathogens, detect residual disease markers, and identify treatable mutations of diseases. Due to the need for amplification of nucleic acids for detection with benchtop equipment, there are challenges associated with providing rapid diagnostics outside the clinical laboratory.

The device developed by Ozcan Labs (above) is a “field-portable and cost-effective mobile-phone-based nucleic acid amplification and readout platform [that] is broadly applicable to other real-time nucleic acid amplification tests by similarly modulating intercalating dye performance. It is compatible with any fluorescence-based assay that can be run in a 96-well microplate format, making it especially valuable for POC and resource-limited settings.” (Caption and photo copyright: American Chemical Society.)

Using the new mobile POC nucleic acid testing system developed by Ozcan et al, pathologists can effectively step away from the lab to perform rapid POC testing and accelerated diagnostics onsite, rather than needing to transport materials to and from a central laboratory. The mobile testing assay enables pathologists to carry a medical laboratory with them into the field, or into limited-resource or decentralized testing environments, without sacrificing quality or sensitivity. And according to the ACS Nano article, at a relatively low-cost compared to benchtop nucleic acid testing equipment.

In an article published in Future Medicine, Ozcan and Hatice Ceylan Koydemir, PhD, a post-doctoral researcher in electrical engineering at UCLA, comment on the growing interest in mobile POC diagnostics, stating that smartphone-based devices and platforms have the potential “to be used for early detection and prevention of a variety of health problems.”

According to the article, smartphone-based sensing and imaging platforms have been developed to:

  • Analyze chemicals and biological specimens;
  • Perform advanced cytometry and bright-field/fluorescence microscopy;
  • Detect bacterial contamination;
  • Image nano-sized specimens;
  • Detect antimicrobial drug resistance; and
  • Analyze enzyme-linked immunosorbent assay (ELISA)-based testing.

Smartphones, according to Ozcan and Koydemir, have been adapted to a range of biomedical measurement tools, “have the potential to transform traditional uses of imaging, sensing, and diagnostic systems, especially for point-of-care applications and field settings,” and can provide speedy results.

A ‘Highly Stable’ and Sensitive System

The proof-of-concept study of Ozcan Lab’s new smartphone-based detection system and new detector dye mixture was led by Janay E. Kong, PhD in bioengineering at UCLA, with the help of Ozcan and fellow professors Dino Di Carlo, PhD, professor of bioengineering and mechanical and aerospace engineering at UCLA, and Omai Garner, PhD, associate professor of clinical microbiology at the David Geffen School of Medicine at UCLA.

According to an article in Bioscience Technologies, the new smartphone DNA detection system addresses issues with detection of light emitted from intercalator dyes, which are normally “too subtle and unstable for regular cellphone camera sensors.” The new system uses loop-mediated isothermal amplification (LAMP) to amplify DNA in connection with a newly developed dye that uses hydroxynaphthol blue (HNB) as an indicator.

The inclusion of HNB into the dye, according to the original research study, “yields 20 times higher fluorescent signal change over background compared to current intercalating dyes,” making the results bright enough for smartphone camera sensors without “interfering with the nucleic acid amplification process.” The original study reports that the digital LAMP system and use of the HNB intercalating dye, in fact, provided “significantly enhanced performance compared to a benchtop reader with standard LAMP conditions.”

Ozcan labs shows no signs of slowing down their development of mobile POC diagnostic devices. The development of these smartphone-based tools may provide unique and much-needed equipment for clinical pathologists given the rising interest in mobile healthcare worldwide.

Amanda Warren

Related Information:

UCLA Researchers Make DNA Detection Portable, Affordable Using Cellphones

Mobile Phones Create New Opportunities for Microbiology Research and Clinical Applications

Highly Stable and Sensitive Nucleic Acid Amplification and Cell-Phone-Based Readout

Cellphone System Makes DNA Detection Affordable and Portable

UCLA Device Enables Diagnosis of Antimicrobial Resistance in Any Setting; Could Save Lives Lost to Antimicrobial Resistant Bacteria

UCLA Researchers Develop Lens-Free Smartphone Microscope, Pathologists May Be Able to Take the Clinical Pathology Laboratory Just About Anywhere

Smartphone “Dongle” Achieves Capabilities of Big Clinical Laboratory Analyzers: Diagnoses Three Diseases at Once from Single Drop of Blood

New Fast, Inexpensive, Mobile Device Accurately Identifies Healthcare-Acquired Infections and Communicates Findings to Doctors’ Smartphones and Portable Computers

Pathologists and Researchers Predict Development Trajectory for Biomarker-based Molecular Diagnostics in Support of Translational Medicine

Tiny, Simple-to-Use Lensless Microscope Might Soon Find a Place in Pathology

Is mHealth an Opportunity or Threat to Medical Laboratories and Pathology Groups?

As cognitive and cloud computing continue to advance, and mobile technologies become more accessible across the globe, innovative apps and mobile attachments are using algorithms to replace the need for complex and time-consuming diagnostic tests

Mobile healthcare—also known as mHealth—is attracting plenty of research dollars as entrepreneurs look for ways improve consumers’ access to various medical services in ways that could reduce healthcare costs. For that reason, some mHealth solutions may be used by clinical laboratories and pathology groups to give patients faster access to diagnostic services and information about medical laboratory tests.

Most mHealth solutions excel at doing a single, defined task well. In some cases, they are faster and as accurate as human-based testing or observation. However, few solutions can tackle complex diagnostics, such as determining the pathogens involved in sepsis. And mHealth cannot replace the human element of communication and empathy, which will always have a place in the medical process. (more…)

Multi-channel Smartphone Spectrometer Enables Clinical Laboratory Testing Quickly and Accurately in Remote Regions

Researchers say high accuracy of this $150 portable optical spectrometer enables mobile diagnostic technologies to achieve pathology test results comparable to traditional spectrometers costing far more

What’s the latest thing in a smartphone diagnostic device? It’s a multi-channel smartphone spectrometer! Researchers at Washington State University (WSU) designed the device to detect human cancer biomarkers. It’s hoped that this device can improve cancer detection in rural areas where clinical laboratories may not be easily accessible.

The Multichannel Smartphone Spectrometer (MSS) is a highly accurate, low-cost, portable diagnostic device capable of detecting human cancer biomarkers equally well in rural and busy hospital settings. (more…)

New Fast, Inexpensive, Mobile Device Accurately Identifies Healthcare-Acquired Infections and Communicates Findings to Doctors’ Smartphones and Portable Computers

Use of these new technologies creates opportunities for clinical laboratories and pathologists to add more value when collaborating with physicians to advance patient care

Ongoing improvements in point-of-care testing are encouraging one major academic medical center to apply this mode of testing to the diagnosis of hospital-acquired infections (HAIs). This development should be of interest to clinical laboratory professionals and pathologists, since it has the potential to create a different way to identify patients with HAIs than medical lab tests done in the central laboratory.

Massachusetts General Hospital (MGH), Harvard Medical School’s (HMS’) largest teaching hospital, has developed a prototype diagnostic system that works with doctors’ smartphones or mobile computers. The hand-held system can identify pathogens responsible for specific healthcare-acquired infections (HAIs) at the point of care within two hours, according to an MGH statement.

The researchers noted that 600,000 patients develop HAIs each year, 10% of which die, and that costs related to HAIs can reach $100 to $150 billion per year. However, as Dark Daily reported, the Centers for Medicare and Medicaid Services (CMS) does not reimburse hospitals for certain HAIs. (See Dark Daily, Consumer Reports Ranks Smaller and Non-Teaching Hospitals Highest in Infection Prevention,” October, 30, 2015.) Thus, the critical need to identify from where the infection originated, which generates a significant proportion of samples tested at the clinical laboratories of the nation’s hospitals and health systems.

Therefore, pathologists and medical laboratory scientists will understand that shifting some of that specimen volume to point-of-care testing will change the overall economics of hospital laboratories.

Smartphone-based Genetic Test for HIAs

The MGH research team created a way to do accurate genetic testing in a simple device powered by a system they call Polarization Anisotropy Diagnostics (PAD). The system measures changes in fluorescence anisotropy through a detection probe’s recognition of bacterial nucleic acid, reported Medscape Medical News. More than 35 probes for detecting bacterial species and virulence factors are available.

Optical test cubes are placed on an electronic base station that transmits data to a smartphone or computer, where results are displayed. “In a pilot clinical test, PAD accuracy was comparable to that of bacterial culture. In contrast to the culture, the PAD assay was fast (under two hours), multiplexed, and cost effective (under $2 per assay), wrote the MGH researchers in the journal Science Advances. (more…)

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