Glaucoma is a group of optic nerve-damaging eye conditions. The optic nerve transmits visual information from your eye to the brain. Optic nerve damage is often associated with high pressure in the eye (as is often the case with glaucoma). Still, glaucoma can occur even if you have normal eye pressure.

While glaucoma can occur at any age, it is more common among older adults. The disease is a leading cause of blindness for people over age 60.

Today we explore a United Kingdom study that explores the relationship between insufficient sleep and glaucoma risk.

Glaucoma basics

Glaucoma worsens over time and tends to run in families. Glaucoma can lead to permanent vision loss or blindness within a few years if the damage worsens.

Most individuals have no early symptoms (such as pain or visual loss). By regularly visiting your eye doctor, you are more likely to diagnose and manage glaucoma before you have a long-term visual loss.

Once the vision is lost, you cannot recover it. However, lowering eye pressure may help you keep the vision you have. Fortunately, most individuals with glaucoma who are diligent about regular eye examinations and follow their treatment plan will retain their vision.

Glaucoma causes

Normally, our eye’s fluid (or aqueous humor) flows out of the eye through a mesh-like channel. The fluid can build up if the channel is blocked (or if the eye produces too much fluid). Unfortunately, we don’t know the cause of the blockage, but one can inherit risk.

Less common causes of glaucoma include:

• Eye injury (such as from a chemical or blunt trauma; uncommonly from eye surgery for another condition)
• Eye infection, severe
• Blood vessel blockage in the eye
• Inflammatory conditions
• Steroid medicines

Glaucoma typically affects both eyes but may be worse in one than the other.

Glaucoma types

According to WebMD, there are two main forms of the condition: open-angle and angle-closure glaucoma. Open-angle (wide-angle) glaucoma is the most common type. The eye’s drain structure (trabecular meshwork) looks normal, but the fluid doesn’t flow out as it should.

With acute or chronic angle-closure (narrow-angle) glaucoma, the eye doesn’t drain properly because the drainage space between your iris and cornea is too narrow. The result? A sudden buildup of pressure within the eye. Angle-closure glaucoma is associated with cataracts and farsightedness.

Less common types include normal-tension glaucoma, a condition with visual blind spots. Alternatively, the optic nerve is damaged, even though the intraocular pressure is normal. Some view it as a form of open-angle glaucoma.

Finally, pigmentary glaucoma involves very small pigment pieces from your iris (the colored portion of your eye) getting into the eye fluid and clogging the drainage canals.

Glaucoma risk factors

While glaucoma most commonly affects adults over 40, one can suffer from the disease at any age. African-Americans are more likely to suffer from the condition at a younger age and with more vision loss.

After cataracts, glaucoma is the leading cause of blindness in African Americans. The Glaucoma Research Foundation explains that many people are unaware that:

Glaucoma strikes earlier and progresses faster in African Americans. The glaucoma risk is 1.2-times higher if the condition runs in the family. Other factors putting African Americans at even greater risk include age over 40, extreme nearsightedness, high blood pressure, diabetes, and prolonged steroid use.

Glaucoma is five times more common among African Americans. Glaucoma-related blindness is roughly six times more common. Glaucoma often occurs at an earlier age in African Americans — on average, about ten years earlier than in other ethnic populations.

We don’t know why African Americans have a higher risk, but inherited genetics plays a role.

Other glaucoma risk factors include:

• African American, Russian, Irish, Japanese, Hispanic, Scandanavian, or Inuit ancestry
• Age over 40
• A family history of glaucoma
• You are nearsighted or farsighted.
• Poor vision
• Diabetes
• Steroid medications such as prednisone
• Certain bladder control or seizure drugs. Select over-the-counter cold medicines may raise the risk.
• Eye injury
• Corneas that are thinner than usual
• Hypertension, heart disease, diabetes, or sickle cell anemia
• High eye pressure

Glaucoma symptoms and diagnosis

Symptoms

Most individuals who have open-angle glaucoma do not have symptoms (unless the disease is late in its progression). The primary symptom is a loss of peripheral (side) vision.

Angle-closure glaucoma symptoms typically come on more rapidly and are more apparent. Because damage can quickly occur, if you have any of the following symptoms, please seek medical care: Visual loss; seeing halos around lights; eye redness; eye pain; an upset stomach or vomiting; a hazy-appearing eye (especially in infants).

Glaucoma diagnosis

Many have glaucoma and don’t know it. Regular eye exams are critical to catching glaucoma or other eye problems. Clinicians may perform a dilated eye exam to widen pupils and view the optic nerve at the back of the eyes.

Genioscopy involves an examination of the angle where the cornea and the iris meet. An ocular pressure test (tonometry) measures eye pressure, while optical coherence tomography (OCT) searches for changes in the optic nerve.

Other approaches include pachymetry to measure corneal thickness and a visual acuity test (eye chart) to look for vision loss. A slit lamp exam examines the inside of your eye with a special microscope known as a slit lamp. Finally, a visual field test (perimetry) looks for peripheral vision changes.

Sleep insufficiency and glaucoma

A new research study illustrates an association between poor sleep and glaucoma. The study drew on a database of over 400,000 individuals (in the UK Biobank) to explore links between sleep and vision loss.

The study looked at sleep behavior, including too much, too little, insomnia, daytime sleepiness, snoring, and being a “morning lark” or “night owl.” The study defined normal sleep duration as seven to nine hours. After tracking the health and lifespan of the participants until the first diagnosis of glaucoma, death, emigration, or end of monitoring in 2021, researchers identified 8,690 glaucoma cases.

Here are the results:

Frequent daytime sleepiness was associated with a 1.2-fold higher risk for glaucoma. The risk rose 1.12-times with insomnia and 1.08-times with short or long sleep duration. Snoring was associated with a 1.04-fold higher risk.

Compared with those without glaucoma, participants with the condition tended to be male and older, and have high blood pressure, diabetes, or smoking history.

The risk increases associated with insufficient sleep appear to be relatively small. In addition, the researchers do not establish causality.

The researchers note that glaucoma might influence sleep patterns rather than vice versa. They also offer some possible biological explanations for the association. The internal pressure of the eye rises when we lie down or when sleep hormones are off (as happens with insomnia).

Furthermore, anxiety and depression (sometimes associated with insomnia) may increase eye pressure, possibly due to dysregulated cortisol stress hormone production.

Alternatively, repeated episodes of low oxygen secondary to sleep apnea may also damage the optic nerve.

I want to use this new research as a springboard to talking about glaucoma. Here are some steps from the Mayo Clinic that may allow you to detect and manage glaucoma early, hopefully preventing visual loss (or slowing its pace).

• Get regular eye examinations. Generally, the American Academy of Ophthalmology suggests an eye exam every five to 10 years if you are under age 40; every two to four years if you are 40 to 54; every one to three years if you are 55 to 64, and every year or two if you’re older than 65.
• You’ll need more frequent screening if you have a higher risk of glaucoma. Ask your healthcare provider to guide you to an appropriate screening program.
• Know your family’s eye health history. Glaucoma tends to run in families.
• Wear eye protection. Serious eye injuries can cause glaucoma. Please wear appropriate eye protection when you play sports or use power tools.
• Take prescribed eye drops regularly, as directed (even if you have no symptoms).

Other tips

Finally, don’t smoke, and watch your caffeine intake. The latter can increase your eye pressure. Elevate your head when you sleep, for example, with a wedge pillow to lower eye pressure.

Learn more here about glaucoma:

Glaucoma

Glaucoma is a condition that damages your eye’s optic nerve. It gets worse over time. It’s often linked to a buildup of…

www.webmd.com.

Thank you for joining me today.

The post Sleep May Be Associated with Eye Health appeared first on Medika Life.

Nasopharyngeal swabs are the most effective means of detecting COVID-19 infection, offering detection rates of 92 to 100 percent. That’s the conclusion of Cornell University (USA) researchers.

COVID test accuracy

The scientists obtained samples from patients; more specifically, they got four types of specimens:

• Nasopharyngeal swabs (the Q-tip-like collector goes deep into your nose)
• Anterior nares swabs (front of the nostril)
• Saliva
• Sublingual swabs(under the tongue)

The researchers obtained the samples from individuals with symptoms, individuals without symptoms, and subjects who had recovered from illness.

Covid detection rates by test type

Let’s look at the results by test type:

The nasopharyngeal samples had the best detection rate, from 92 to 100 percent. This high detection rate seems logical, as the COVID virus replicates in the uppermost portion of the nose.

Samples from the front of the nostril and saliva proved fairly good, too; about 92 to 96 percent effective for patients with symptoms. On the other hand, when patients had no symptoms, these approaches worked 75 to 92 percent of the time.

Under the tongue sampling proved suboptimal, with detection rates of only 40 to 60 percent for patients with symptoms and 25 to 42 percent for those without symptoms.

Overall, detection rates appeared highest for those with symptoms, ranging from 92 to 100 percent. The detection rate dropped to 75 to 96 percent for those without symptoms. Finally, once a patient no longer had symptoms, detection proved challenging.

I find nasopharyngeal swab tests — wherein the swab is sent far back inside the nostril — dreadful. But this approach is more effective at finding COVID-19 than are swabs put just inside the nose, swabs under the tongue, or saliva tests.

Fortunately, samples obtained from the front of the nose are reasonably accurate (and easier to perform). Study researcher Diego Diel offers this relevant observation:

“We were surprised at the short time in which infectious virus was detected. The data aligns with current US Centers for Disease Control guidelines and its decision to decrease patient isolation periods from an initial 14-day period to 10 and ultimately to five.”

Here’s a piece I wrote earlier on long COVID:

Long Covid: Could This Be Why?MICROCLOTS. COULD THEY EXPLAIN the mystery of why some who get a COVID19 infection suffer for long periods? Three…medium.com

The post Covid Testing: Are Nasal Swabs Good? appeared first on Medika Life.

The post Largest Coordinated HIV Testing Event in the Nation on June 27th appeared first on Medika Life.

Healthcare ethnography can help your hospital to discover front-line insights to transform patient care and the patient experience and save money.

In some places, outdated industry standards have become ritualized. A proactive approach to innovation and improvement is not always possible for hospital staff immersed in their daily routines.

Ethnography offers your hospital a solution to achieve and maintain operational efficiency in what is often a disruptive healthcare environment.

What is Ethnography?

Ethnography studies the culture and habits of people in specific situations. In healthcare, it can be applied to:

• Explain discrepancies between what patients say and what they do.
• Identify needs that people can’t articulate explicitly.
• Describe both usage and meaning of healthcare services.
• Put a human face on market data through real-life stories.
• Evaluate current products or services or create brand new ones.
• Help collect and organize multiple viewpoints and represent patients in an unbiased manner.
• Directly provide patient models that can quickly generate many good ideas.

Gaining front line insights from the viewpoint of patients, their families, and carers is essential to improve the quality of patient care. Our ethnographers use this qualitative research methodology to understand how to improve individual departments within your hospital, leading to greater patient and family satisfaction. The care coordination within a bundled payment model is also enhanced.

Our holistic approach involves gathering subjective insights to accompany data analytics and equip your hospital with the tools it needs for continuous innovation and improvement.

Our Process

The first part of the process is to illustrate a Patient Journey Map™ to identify existing challenges within your hospital. Our experienced ethnographers then collaborate with your team to create sustainable solutions.

One pathway to this process (VIE Healthcare), is to adopt a holistic approach that engages employees, patients, and their families by examining and analyzing their behaviors, attitudes and emotions.

The result is the discovery of valuable front line insights to empower your organization with opportunities that innovate and improve products and services to meet those needs.

Our team of ethnographers can uncover and solve hidden, complex issues in the delivery of your care and operational performances across your hospital, which can result in millions of dollars in lost revenue.
Our process involves:

• Engagement with, and interviewing your employees, allowing them to contribute individual insights and ideas. This helps us to recommend improvements and enhance patient care.
• Shadowing surgical cases from the front line to observe the decision-making process and staff performance. This gives us the insight to identify inefficiencies or areas where shortcuts are made often due to a lack of effective training or awareness of regulations.

Benefits of Ethnography in Healthcare

In summary, ethnography offers numerous benefits in your hospital, including:

• Target the actual needs of patients and families, saving valuable time and resources.
• Identify process improvements that have a tangible effect on your staff’s daily activities.
• Improve staff satisfaction by allowing them to be heard and addressing their needs.
• Redesign care through a collaborative approach for patients, families and staff.
• Multi-disciplinary care coordination throughout the care continuum.
• Improve patient satisfaction scores that directly impact bundle payments and reimbursement.
• Transform the patient experience.
• Reduce your hospital purchased costs.

Ethnography for Exceptional Patient Care

The insights we discover during our analysis reveal the unspoken needs of your patients and families to transform the patient experience and deliver a smoother patient journey through your organizational boundaries.

Our insights reduce errors, duplications and delays often experienced during processes such as “hand-offs.”

The result is improved health outcomes and a more enriching experience for patients and their families, positioning your hospital as a thought leader in the healthcare sector. As value-based care comes to the forefront, it becomes an essential part of driving margin improvement for the survival of your hospital.

The post Healthcare Ethnography: Discover Front Line Hospital Insights appeared first on Medika Life.

Fortunately, age-adjusted death rates are falling globally. Death rates show a 17 percent decline from 1990 to 2016. Today we look at some advances in the management of advanced breast and melanoma cancers that have spread to distant sites of the body.

Breast cancer

Let’s be clear: When breast cancer has spread to distant organs (such as the bones, lung, liver, or brain), the disease is not currently curable. What has me excited this morning is a recent report about long-term survival for two subtypes of breast cancer. Let’s get right to the results:

Patients with two of the three major types of advanced breast cancer now have a median overall survival of at least 5 years, which is roughly a doubling of survival time over the past decade.

The two types of advanced breast cancer for which survival times have doubled over the past decade are HER2-positive (HER2+) breast cancer and ER-positive (ER+) breast cancer. HER2-positive means that the cancer cells have a particular protein sticking out like antennae.

Individuals with HER2-positive disease represent about 25 percent of patients with metastatic breast cancer and now commonly live as long as ten years. Doctors can use drugs that target the HER2 pathway that drives cell growth and division. The best-known of these is trastuzumab (Herceptin).

For those of you who would like to hear more about Herceptin, try this book:

Her-2: The Making of Herceptin, a Revolutionary Treatment for Breast CancerAmazon.com: Her-2: The Making of Herceptin, a Revolutionary Treatment for Breast Cancer eBook: Bazell, Robert

To see a film representation of the passionate and inspiring story of Dr. Dennis Slamon, the UCLA (USA) doctor who helped develop the breast cancer drug, Herceptin, try this:

Living ProofTop-rated Lifetime movie! Dr. Dennis Slamon has reached a breakthrough in his career. He has helped to develop a new…

Melanoma

You may have heard about the revolutionary cancer management tool known as immunotherapy.

A group of investigators from around the world reported the results of using a combination of two immunotherapy drugs for advanced melanoma. Following treatment with nivolumab and ipilimumab drugs yielded a more prolonged progression-free survival and overall survival than with only one immunotherapy drug.

Striking to me are the long-term outcomes:

At a minimum follow-up of five years, the median overall survival was more than five years (median not yet reached) in the group that received two immunotherapy drugs in combination. Over half of patients with cancer spread to distant sites were still alive at the five-year mark.

Chronic disease survivors. Former United States President Jimmy Carter presented with advanced melanoma — his disease had spread to his brain. You know the rest of the story: First, doctors bombarded his cancer in the brain with a highly focused, high-dose radiation therapy known as radiosurgery.

The high-dose radiation therapy damaged the cancer cells in the brain. These dying cells then released substances into the bloodstream, attracting the attention of immune cells.

Carter then received immunotherapy; more specifically, he got a drug known as pembrolizumab (Keytruda). Three months after immunotherapy, the then-91-year old discovered that his tumors were gone. The drug supported his immune system’s response and appears to have completely eliminated any residual cancer.

More than five years later, President Carter has no evidence of cancer remaining. If you want to learn more about immunotherapy, please go here:

What is Immunotherapy?As of October 2021, the U.S.www.cancerresearch.org

You will not be surprised to learn that the 2018 Nobel Prize in Physiology or Medicine was awarded jointly to two cancer immunotherapy researchers, James P. Allison, Ph.D. of The University of Texas MD Anderson Cancer Center, and Dr. Tasuku Honjo of Kyoto University in Japan.

The Nobel Prize committee honored Allison and Honjo for their work on uncovering ways to activate the immune system to attack cancer.

Thank you for joining me today in exploring the promise of targeted therapy and immunotherapy in the management of advanced cancer.

The post Making Advanced Cancer a Chronic Disease appeared first on Medika Life.

AMSTERDAM/PRNewswire/ — StrokeViewer enables physicians to provide every stroke patient with the right treatment, as fast as possible. Two million brain cells die every minute until blood flow is restored (Saver, 2006), starting treatment earlier can make the difference between recovery or life-long disability.

Date of Release: Nov. 26, 2020 

This week the FDA approved a 510k application (FDA K200873) for StrokeViewer LVO, an artificial intelligence algorithm for fast triaging of stroke patients. StrokeViewer LVO detects image characteristics associated with a Large Vessel Occlusion (LVO) and alerts physicians. The FDA application was supported by a multi-center clinical study where the performance of the algorithm was retrospectively evaluated in 384 patients from multiple US stroke centers. An expert panel assessed the data to identify LVOs (ICA, M1 and M2) and comparison with the algorithm showed results exceeding the performance goal.

StrokeViewer was developed by the Dutch medtech company NICO.LAB. The cloud-based solution uses artificial intelligence to support physicians in the emergency stroke setting. The FDA-cleared LVO algorithm is embedded in a cloud-based system that sends a notification to the medical specialists involved just minutes after a stroke patient arrives in the hospital. The physicians are able to use their smartphones, in the hospital but also at home, to inspect the CT images in a web viewer and diagnose stroke.

“Medical specialists are under enormous pressure to make fast decisions day and night, but it’s not easy. Complicated assessment and interhospital communication sadly make life difficult for physicians motivated to treat stroke victims effectively” – said Merel Boers, CEO and co-founder of NICO.LAB. “With our first FDA clearance we are now able to show U.S. physicians how impactful the combination of human and artificial intelligence is. And yes, more will follow as we are fully committed to unlocking the full healthcare potential for every patient.”

StrokeViewer is currently in use in Australia and Europe where it has proven to reduce the time from hospital arrival to start treatment for patients with acute stroke, leading to reduced patient disability in the short-term and more clot removal treatments performed.

Stroke is a leading cause for serious long-term disability in the United States. The economic burden of stroke exceeds an astonishing $100 billion per annum (Girotra, Lekoubou et al., 2020). Stroke incidence and associated costs are rising drastically due to an aging population and increasing unhealthy lifestyle. NICO.LAB is dedicated to playing a crucial role in reducing stroke related costs and improving quality of life of patients by combining human and artificial intelligence to revolutionize emergency stroke care.

About

NICO.LAB was founded in 2015 as a spin-off from the Amsterdam University Medical Center in the Netherlands. An international team of researchers, developers and physicians connects human & artificial intelligence to empower physicians in emergency care with end-to-end solutions. The company is active in Europe, Asia, Australia and the United States. StrokeViewer consists of a set of tools to support the entire stroke workflow. StrokeViewer LVO is the first with FDA approval. Local availability of StrokeViewer functionality is subject to applicable CE marking, TGA and FDA approval (actual status on www.nico-lab.com).

References
Saver, 2006 – “Time is brain—quantified.” Stroke 37.1 (2006): 263-266
FDA K200873 – StrokeViewer LVO is approved as HALO under FDA submission number K200873
Girotra, Lekoubou et al. 2020 – “A contemporary and comprehensive analysis of the costs of stroke in the United States” JNS-journal, volume 410, 116643

Contact

Mike Moolenbel
Head of Marketing & Communications
mmoolenbel@nico-lab.com
+31642228955

Related Images

nico-lab.jpg
NICO.LAB
NICO.LAB logo

strokeviewer.jpg
StrokeViewer
StrokeViewer logo

merel-boers-ceo-founder.jpg
Merel Boers (CEO & Founder)
Merel Boers (CEO & Founder)

strokeviewer-lvo.jpg
StrokeViewer LVO
StrokeViewer on smartphone

Related Links

NICO.LAB website

NICO.LAB LinkedIn page

Related Video

SOURCE NICO.LAB B.V.

The post NICO.LAB Ready to Revolutionize U.S. Stroke Care After FDA Clearance appeared first on Medika Life.

With a sealed user interface and revolutionary ZONE Sonography® Technology+, the new ME8 Ultrasound System combines best-in-class image quality with an intuitive user experience

MAHWAH, N.J., Oct. 23, 2020 /PRNewswire/ — Mindray, a global leader in the development of innovative healthcare technology, today announced the launch of a revolutionary new product, the ME8 Ultrasound System. With a weight and thickness of just 6.6 pounds and 1.7 inches, respectively, the ME8 System’s main unit is one of the lightest and thinnest laptop-based machines in the industry. In addition, this compact, durable, and powerful System houses advanced software and hardware built to maximize performance in all applications.

“Since its founding, Mindray has been dedicated to developing innovative and accessible ultrasound solutions for the point of care environment,” said Wayne Quinn, President of Mindray North America. “Given the continuous evolution of the healthcare industry as a whole, and the ongoing fight against COVID-19, we are proud to be able to provide state-of-the-art solutions like the ME8 that address the pressing challenges of today, while supporting our partners’ long-term goals.”

The ME8 Ultrasound System has been thoughtfully designed to overcome the obstacles clinicians face in today’s challenging healthcare environments. With a sealed user interface for ease of cleaning and disinfection and revolutionary software-based ZONE Sonography® Technology⁺, the ME8 Ultrasound System combines best-in-class image quality with an intuitive and customizable user experience to help ensure reliable and efficient diagnosis during the most challenging exams.

Using AI-powered smart tools (Smart B-Line, Smart VTI, Smart IVC), this portable ultrasound system can help assess volume status and fluid responsiveness in critically ill patients. With groundbreaking technologies like eSpacial Navi^TM and iNeedle+^TM, the ME8 offers the most advanced suite of needle guidance and enhancement technologies. Additionally, when used with the U-bank, the System provides up to eight hours of battery life allowing for all-day scanning.

“As point of care ultrasound continues to break through barriers in a variety of clinical settings, it is our responsibility here at Mindray to continue to push ultrasound technology forward,” said Maher Elhihi, Director of Marketing, Ultrasound. “At the end of the day, our goal is to provide greater access to leading-edge imaging technologies that enable better patient care, and we are confident that the ME8 System addresses these evolving needs.”

Through innovative solutions like the ME8 Ultrasound System, Mindray continues to drive its mission forward, advancing medical technologies to make healthcare more accessible. Click here to watch the launch event.

About Mindray

Mindray is a leading developer, manufacturer, and supplier of medical device solutions and technologies used in healthcare facilities around the globe. We believe we can change lives by making the most advanced healthcare technology attainable for all. We do this by empowering healthcare professionals through innovative, high-value solutions that help create the next generation of life-saving tools across three primary business segments: medical imaging, patient monitoring and life support, and in-vitro diagnostics. Mindray maintains its global headquarters in Shenzhen, China; Mindray North America is headquartered in Mahwah, New Jersey. Our Ultrasound Innovation Center is located in San Jose, California, with additional facilities in major international markets around the world. For more information, please visit http://www.mindray.com. 

SOURCE Mindray North America

The post Mindray’s New POC Ultrasound System Redefines What’s Possible appeared first on Medika Life.

SILVER SPRING, Md., Sept. 23, 2020 /PRNewswire/ — Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first serology (antibody) point-of-care (POC) test for COVID-19. The Assure COVID-19 IgG/IgM Rapid Test Device was first authorized for emergency use by certain labs in July 2020 to help identify individuals with antibodies to SARS-CoV-2, indicating recent or prior COVID-19 infection. Today, that EUA is being reissued to authorize the test for POC use using fingerstick blood samples. This authorization means that fingerstick blood samples can now be tested in POC settings like doctor’s offices, hospitals, urgent care centers and emergency rooms rather than having to be sent to a central lab for testing.

“Authorizing point-of-care serology tests will enable more timely and convenient results for individuals who want to understand if they have previously been infected with the virus that causes COVID-19,” said FDA Commissioner Stephen M. Hahn, M.D. “Until today, serology test samples were generally only able to be evaluated in a central lab, which can be time consuming and use additional resources to transport samples and run the test. As more and more point-of-care serology tests are authorized, they will help conserve those resources and may help reduce processing time for other types of COVID-19 tests, as less time is spent on serology tests.”

Nearly 50 serology tests have been granted an EUA since the start of the pandemic. The Assure test is a lateral flow assay and is authorized for use with venous whole blood, serum, plasma and fingerstick whole blood. This serology POC test, unlike POC COVID-19 diagnostic tests, uses a blood sample from the fingertip to run the test.

The FDA wants to remind patients that it is unknown how long antibodies persist following infection and if the presence of antibodies confers protective immunity, so they should not interpret results from a serology test as telling them they are immune, or have any level of immunity, from the virus. Due to these unknowns, the FDA cautions patients against using the results from these tests, or any serology test, as an indication that they can stop taking steps to protect themselves and others, such as stopping social distancing, discontinuing wearing masks or returning to work.

The FDA also wants to remind the public that serology tests should not be used to diagnose an active infection, as they only detect antibodies the immune system develops in response to the virus – not the virus itself. It is also important to remember that in a population with low prevalence, even high-performing antibody tests may produce as many or more false results as true results because the likelihood of finding someone who has been infected is very small. Thus, it is necessary to consider that the results from two serology tests may be needed to generate reliable results. 

The Assure COVID-19 IgG/IgM Rapid Test Device is currently the only FDA authorized COVID-19 POC serology test and is available by prescription only. The FDA continues to work with test developers to expand access to COVID-19 testing.

Media Contact: Jim McKinney, 240-328-7305
Consumer Inquiries: 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration

The post Coronavirus: FDA Authorizes First Point-of-Care Antibody Test appeared first on Medika Life.

• Abbott’s BinaxNOW™ COVID-19 Ag Card is a rapid, reliable, highly portable, and affordable tool for detecting active coronavirus infections at massive scale.
• Test delivers results in just 15 minutes with no instrumentation, using proven lateral flow technology with demonstrated sensitivity of 97.1% and specificity of 98.5% in clinical study.
• Abbott to offer a no-charge complementary phone app, which allows people to display their BinaxNOW test results when asked by organizations where people gather, such as workplaces and schools.
• Company will ship tens of millions of tests in September, ramping to 50 million tests a month at the beginning of October.

DATE OF RELEASE: Aug. 26, 2020 

ABBOTT PARK, Ill/ — Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its BinaxNOW™ COVID-19 Ag Card rapid test for detection of COVID-19 infection. Abbott will sell this test for $5. It is highly portable (about the size of a credit card), affordable and provides results in 15 minutes. BinaxNOW uses proven Abbott lateral flow technology, making it a reliable and familiar format for frequent mass testing through their healthcare provider. With no equipment required, the device will be an important tool to manage risk by quickly identifying infectious people so they don’t spread the disease to others.

Abbott will also launch a complementary mobile app for iPhone and Android devices named NAVICA™. This first-of-its-kind app, available at no charge, will allow people who test negative to display a temporary digital health pass that is renewed each time a person is tested through their healthcare provider together with the date of the test result. Organizations will be able to view and verify the information on a mobile device to facilitate entry into facilities along with hand-washing, social distancing, enhanced cleaning and mask-wearing.

“We intentionally designed the BinaxNOW test and NAVICA app so we could offer a comprehensive testing solution to help Americans feel more confident about their health and lives,” said Robert B. Ford, president and chief executive officer, Abbott. “BinaxNOW and the NAVICA app give us an affordable, easy-to-use, scalable test, and a complementary digital health tool to help us have a bit more normalcy in our daily lives.”

In data submitted to the FDA from a clinical study conducted by Abbott with several leading U.S. research universities, the BinaxNOW COVID-19 Ag Card demonstrated sensitivity of 97.1% (positive percent agreement) and specificity of 98.5% (negative percent agreement) in patients suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.

“The massive scale of this test and app will allow tens of millions of people to have access to rapid and reliable testing,” said Joseph Petrosino, Ph.D., professor and chairman, Molecular Virology and Microbiology, Baylor College of Medicine, whose labs have been leading efforts to provide COVID-19 testing for the college and Harris County. “With lab-based tests, you get excellent sensitivity but might have to wait days or longer to get the results. With a rapid antigen test, you get a result right away, getting infectious people off the streets and into quarantine so they don’t spread the virus.”

Under FDA EUA, the BinaxNOW COVID-19 Ag Card is for use by healthcare professionals and can be used in point-of-care settings that are qualified to have the test performed and are operating under a CLIA (Clinical Laboratory Improvement Amendments) Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Within these settings, the test can be performed by doctors, nurses, school nurses, medical assistants and technicians, pharmacists, employer occupational health specialists, and more with minimal training and a patient prescription.  

“Our nation’s frontline healthcare workers and clinical laboratory personnel have been under siege since the onset of this pandemic,” said Charles Chiu, M.D., Ph.D., professor of Laboratory Medicine at University of California, San Francisco. “The availability of rapid testing for COVID-19 will help support overburdened laboratories, accelerate turnaround times and greatly expand access to people who need it.”

Currently, AdvaMed (The Advanced Medical Technology Association) estimates that test manufacturers are shipping about 1 million tests per day. Abbott will ship tens of millions of tests in September, ramping to 50 million tests a month at the beginning of October. The company has invested hundreds of millions of dollars since April in two new U.S. facilities to manufacture BinaxNOW at massive scale.

The BinaxNOW COVID-19 Ag Card can be used as a first line of defense to identify people who are currently infected and who should isolate themselves to help prevent the spread of the disease. It is intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in nasal swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.

As a near-person rapid antigen test, BinaxNOW was engineered for point-of-care settings, near-patient, and not for reference labs. Patient samples should be tested immediately and should not be diluted in viral transport media.

NAVICA mobile app will help facilitate return to daily activities
Abbott is also offering a mobile app at no charge that will allow people to display their results obtained through a healthcare provider when entering facilities requiring proof of testing. The NAVICA app is optional and an easy-to-use tool that allows people to store, access and display their results with organizations that accept the results so people can move about with greater confidence. The app is supported by Apple and Android digital wallets and will be available from public app stores in the U.S.

“While BinaxNOW is the hardware that makes knowing your COVID-19 status possible, the NAVICA app is the digital network that allows people to share that information with those who need to know,” said Ford. “We’re taking our know-how from our digitally-connected medical devices and applying it to our diagnostics at a time when people expect their health information to be digital and readily accessible.”  

If test results are negative, the app will display a digital health pass via a QR code, similar to an airline boarding pass. If test results are positive, people receive a message to quarantine and talk to their doctor. As they’re required to do for all COVID-19 tests, healthcare providers in all settings will be required to report positive results to the CDC and other public health authorities, regardless of whether they use the app. The digital health pass is stored in the app temporarily and expires after the time period specified by organizations that accept the app.

The app’s user interface is supported by a back-end digital infrastructure that is cloud-based, scalable and secure. It’s been designed to support a very large number of users and enable access from anywhere. The app is not for contact tracing and only collects a person’s first and last name, email address, phone number, zip code, date of birth and test results.

About the BinaxNOW COVID-19 Ag Card Test
The BinaxNOW COVID-19 Ag Card is an assay for the qualitative detection of specific antigens to COVID-19 in the human nasal cavity. A simple nasal swab is used to collect specimens from people suspected of having an active infection. No equipment is required to process samples or read test results. In addition, minimal chemical reagents are required, which lessens exposure to biohazardous materials and improves safety for those administering the test.

The BinaxNOW COVID-19 Ag Card is the sixth test that Abbott is launching in the U.S. to help fight the coronavirus pandemic. Abbott’s tests are performed on its high-volume m2000™ and Alinity® m molecular laboratory systems; its ID NOW™ rapid molecular point-of-care platform; antibody tests for its high-throughput ARCHITECT® i1000SR and i2000SR and Alinity™ i laboratory instruments.

Abbott has provided more than 27 million COVID-19 tests in the U.S. to date, including 14 million detection tests and 13 million antibody tests.  

About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The BinaxNOW™ COVID-19 Ag Test Card EUA has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories and patient care settings. The test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

SOURCE Abbott

For further information: Abbott U.S. Media: John Koval, 224-668-5355, Jackie Lustig, 224-668-9857, Darcy Ross, 224-667-3655; For all other countries, see: https://www.abbott.com/corpnewsroom/utilities/media-contacts.html; Abbott Investor Relations: Laura Dauer, 224-667-2299

The post Easy-to-use Covid-19 Antigen Test Gets FDA Emergency Use Authorization appeared first on Medika Life.

One patient may view success as meeting their goal of running a 5K pain-free in under 25 minutes. Anything less is a failure. Another patient may view success as simply finishing the race, even if walking breaks were required.

We don’t all live by the Ricky Bobby mantra of “If you ain’t first, you’re last.” How does everyone else in healthcare measure success?

If you ask a researcher, success may be exceeding the minimally clinically important difference (MCID) or achieving a greater level of change relative to a control (with acceptable p-values and confidence intervals of course).

If you ask Medicare, success is determined when a patient is “functional” (because that isn’t muddy at all…). If you ask a therapist, it may be 0/10 pain, full range of motion, 0% on the Oswestry Disability Index, or a beautiful single leg pistol squat with absolutely no compensation, pain, or difficulty.

But what if the patient doesn’t care about any of those things. How do we juggle the markers of “success” for all relevant stakeholders?

There is not a simple one size fits all answer. What I will try to untangle are the factors that influence how satisfied a patient is with physical therapy.

Why does this matter? Patient satisfaction has a substantial impact on both current and future performance. How a patient perceives their care can dictate the success of interventions, their compliance with care, how they speak about their providers in public, and potentially future reimbursement.

So, patient satisfaction is kind of a big deal.

THE DOMAINS OF PATIENT SATISFACTION

Patient satisfaction questionnaires target many different domains. At PT Solutions, the practice I work for, we ask patients their satisfaction with the treatment they received, the information provided about their condition, their input on goal settings, access to the physical therapy facility, and the availability of convenient appointments. I then receive a scorecard containing all individual scores and the overall satisfaction — an average of the five questions.

This provides us a substantial amount of information and allows us to tease out potential issues and highlight areas of strength.

Quick note, patient satisfaction scores are only valuable if we act on the data. Treating data as a “fun fact” is essentially useless and does not allow us to grow as clinicians. Of course, the data must be accurate.

Ulterior motives and biases can impact the answers patients provide and when the clinician provides the surveys. For example, if a clinician asks a patient how satisfied they are with face to face, they are more likely to receive a positive report. Most people do not like confrontation. This is different for outcome measures.

Outcome measures are designed to highlight functional areas of difficulty. These are best completed with the clinician present. Incorporating Patient-Reported Outcome Measures (PROM) throughout a plan of care has the potential to promote shared decision making between patients, their families, and clinicians.

PROM assessment heightens the provider’s awareness of patients’ health concerns and facilitates communication regarding available medical evidence for optimal treatment options. Geroge et al found patients who were satisfied with symptoms reported higher physical function, lower pain intensity, and less symptom bothersomeness (great word chosen by the authors) at six months.

The two strongest absolute and unique predictors of patient satisfaction with symptoms at six months were whether treatment expectations were met and change in symptom bothersomeness.

Patient satisfaction is most associated with items that reflected a high-quality interaction with the therapist — such as time, adequate explanations, and instructions to patients.

Environmental factors such as clinic location, parking, time spent waiting for the therapist, and type of equipment used are not strongly correlated with overall satisfaction with care.

HOW DO WE GET ACCURATE SATISFACTION DATA?

Clinicians work on their craft daily. They take courses, read the research, engage in clinical conversations, and reflect on past treatments to improve their care. All of these strategies certainly improve the care provided to patients, but they don’t guarantee satisfaction, and outcome scores will improve.

There is an art to administering outcome and satisfaction measures. Here are the strategies I have learned over the past few years as the National Director of Quality and Research for PT Solutions.

A quick caveat, this is not meant to artificially inflate your scores. Furthermore, the goal of obtaining outcomes and satisfaction scores is not simply to inflate the ego and display your awesomeness to everyone.

The purpose is to objectively assess your quality of care and make the necessary adjustments. You may apply guideline adherent care and have mastered your exercise prescription and manual therapy techniques, but if the patients are unhappy and prematurely ending the plan of care then the quality is not high.

Strategy #1: Obtain timely scores.

Patient evaluation worsens as the gap between encounter and completing the measure increases. Our memories become less clear as time passes. I would argue the most important indicator of whether your outcome data is accurate is the ‘days between status and discharge’.

This number represents how many days you treated a patient after obtaining their final outcome measure. The larger the number, the more days you treated and helped a patient without obtaining credit for the improvement. Additionally, patients (and clinicians) have poor long-term memory for our subjective experiences.

The longer a patient goes without a survey, the more they are guessing at how they previously felt.

Clinicians have to decide whether in-person or email surveys will provide more value. They both have benefits and drawbacks. In-person provides more immediate ratings and a larger volume of data, while emails rely on the patient open and answering the survey. However, a patient may feel less pressured to convey disappointment over email.

Strategy #2: Complete the specific actions from the outcome tool on the day a survey is administered.

If a questionnaire asks how difficult it is to walk a quarter-mile, then have the patient walk a quarter mile on the treadmill the day they complete the questionnaire.

Again, this limits the guesswork and provides a more updated assessment.

Strategy #3: Prep the patient but do not hover or bias them.

This strategy falls under ‘obtaining accurate scores’ not ‘maximizing your score, even if it is artificial’. If you hover over a patient during the survey, your body language or the way you ask a question (or your mere presence) may cause scores to be artificially high.

Patients are reluctant to disclose negative attitudes toward a health care provider because of a sense of dependency on patient-provider communication. This doesn’t benefit anyone. Instead, fully explain the survey and be available for questions.

FROM THEORY TO PRACTICE

Ok, your NVBs are top-notch, you are providing evidence-based care, and you are a master at collecting the data appropriately, what can go wrong? In many cases, it will be smooth sailing to world-class outcomes and satisfaction, but there are a few remaining barriers.

The malalignment of therapist and patient goals can be detrimental to satisfaction. It is imperative you are both on the same page with the goals and the methods for obtaining them. This is where motivational interviewing comes into play as this alignment may take weeks to obtain.

Another barrier is understanding what the patient values. They lack the knowledge to assess accurately the technical competence of health care personnel and therefore may only judge satisfaction on outcomes.

Others, however, may care far more about the ‘experience’ and weigh NVBs and the interaction with employees much higher. It is important to recognize these differences and assess them all.

A final thought on this topic is the impact the scores can have on our treatment choices. It can be tempting to provide whatever treatment a patient wants, regardless of the efficacy, to simply satisfy them. This can be a major driver of continued use of treatment with poor efficacy and limits both our progression as a profession and the long-term outcomes of a patient.

Patient satisfaction and outcome measures are by no means the pinnacle of assessment tools. However, they do carry immense value and can help guide improvement for the benefit of our patients and ourselves.

The post How Do We Define Success In Healthcare? appeared first on Medika Life.