‘Inconsistent’ Results for Home Baby Monitors Measuring Vital Signs

Performance of smartphone-integrated baby monitors claiming to measure vital signs varied widely when compared to hospital monitors, researchers found.

Of the two consumer baby monitors tested that use pulse oximetry, one detected hypoxemia, but had an “inconsistent performance,” while the other did not detect hypoxemia and also showed pulse rates that were falsely low, reported Christopher P. Bonafide, MD, of Children’s Hospital of Philadelphia, and colleagues.

One had sensitivity of 88.8% and specificity of 85.7% for hypoxemia, but 0% sensitivity and 100% specificity for bradycardia. The second had sensitivity of 0% and specificity of 100% for hypoxemia, with 0% sensitivity and 82.3% specificity for bradycardia, the authors wrote in JAMA.

They noted that these monitors that measure vital signs are not approved by the FDA, but have been “popular among parents.” The authors also wrote an opinion piece last year that raised questions about these baby monitors.

“We previously discussed the consensus in the pediatric community that there is no medical reason to electronically monitor vital signs in healthy babies at home,” said co-author Elizabeth Foglia, MD, also of Children’s Hospital of Philadelphia in a statement. “Our new study adds serious concerns about the accuracy of these consumer monitors, when we compared them to a standardized hospital monitor in a cohort of sick infants.”

In this study, researchers purchased two smartphone-integrated consumer baby monitors that use pulse oximetry (the Owlet Smart Sock 2 (monitor A) and Baby Vida (monitor B). They examined hospitalized infants ages 0 to 6 months, who were monitored by a reference monitor on one foot, while each consumer monitor was applied randomly on the other foot for 60 minutes while infants were asleep or “awake and calm.”

Of the 30 infants, 50% were girls, and a third were black, and infants had a median age of 39 weeks gestation. The most common diagnosis was bronchiolitis (27%), followed by apnea or brief unresolved explained event, hypoplastic left heart syndrome and double outlet right ventricle (10% apiece).

Researchers recorded 2,466 stable oxygen saturation (SpO₂ ) points and 1,801 stable pulse rate points. With the Owlet product, 12 patients experienced hypoxemia according to the reference monitor. All 12 had “at least 1 simultaneous reading on monitor A, though 5 of 12 had at least one stable normoxemic reading on monitor A during hypoxemia,” the authors found.

With Baby Vida, 14 patients experienced hypoxemia according to the reference monitor, but there were none with “simultaneous hypoxemia readings” on monitor B. However, Baby Vida falsely displayed bradycardic pulse rates in 14 patients when the reference monitor rate was normal, while the Owlet device had no instances of false bradycardic pulse rates.

“As more neonate and infant vital sign monitors emerge in this largely unregulated market, physicians and parents should exercise caution incorporating data from these monitors into medical decisions,” the authors urged.

This work was funded by the Children’s Hospital of Philadelphia Foerderer Award for Excellence and the Division of General Pediatrics.

Bonafide disclosed no conflicts of interest.

Foglia disclosed support from the Zoll Foundation.

• Primary Source

  JAMA

  Source Reference: Bonafide CP, et al “Accuracy of pulse oximetry-based home baby monitors” JAMA 2018; Vol 320, Number 7, p717-719.

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Why the Uninsured Get More Unnecessary Care

American physicians dole out lots of unnecessary medical care to their patients. They prescribe things like antibiotics for people with viral infections, order expensive CT scans for patients with transitory back pain, and obtain screening EKGs for people with no signs or symptoms of heart disease. Some critics even accuse physicians of ordering such services to bolster their revenue.

So what happens when uninsured patients make it to the doctor’s office with coughs, low back pain, or other problems? Do physicians stop ordering all these unnecessary tests and services, out of recognition that most of these patients won’t be able to pay?

A study out of Harvard by Michael Barnett and colleagues provides a rigorous answer to this question. The researchers evaluated how often patients received any of a slew of unnecessary services. They compared patients with private insurance to those with Medicaid (which generally reimburses physicians much less generously than private insurance), and also to those with no insurance.

They found that almost 20% of privately insured patients receive unnecessary services, a staggeringly disturbing number. But even more disturbingly, the same percent of Medicaid enrollees and uninsured patients also receive unnecessary services.

In short, there’s way too much wasteful care, regardless of what kind of insurance people have (or don’t have).

That does not mean that physicians treated all these patients the same way. While the rate of unnecessary care was equal across these three groups of patients, the type of unnecessary services they receive varied. For example, about 1/2 of privately insured patients with upper respiratory infections receive unnecessary antibiotics, as do 1/2 of Medicaid enrollees. But a full 3/4 of uninsured patients with such symptoms receive unnecessary antibiotics.

In addition, among people with back and neck pain, 1/4 of privately insured patients receive narcotics (which are not generally effective for those conditions). The percent receiving narcotics rises to over 1/3 of Medicaid enrollees and almost 1/2 of uninsured patients.

Almost half!

By contrast, unnecessary CT and MRI scans are less common among uninsured patients than among those with either Medicaid or private insurance.

So what’s going on here? I have a few guesses.

1. When physicians are in the habit of ordering EKGs, prescribing antibiotics, and the like, they don’t switch out of that habit based on the insurance status of their patients. They do what they do, regardless of insurance coverage.

2. Patients are powerless. In theory, uninsured patients should push back when their doctors order unnecessary services because they’ll bear the cost. However, giving patients “skin in the game” won’t do much to curb such waste. When doctors tell patients that they need antibiotics or CT scans, they usually go along, even if those interventions will be a financial burden. They do so because they don’t realize the interventions are unnecessary.

3. Contingency antibiotics. When seeing privately insured patients who have been under their care for a long time, physicians might give them a tincture of time for their sinusitis or cough to get better, and encouragement to come back if things persist. But when uninsured patients show up in their office for the first time with the same symptoms, they might fear that such patients will never come back again. In such cases, the risks of unnecessary antibiotics might seem justified.

4. Narcotic insanity. I have no idea why Medicaid enrollees and uninsured patients were more likely to receive unnecessary narcotics than people with private insurance. That is very disturbing. I would be eager to hear the thoughts of clinicians who care for these populations.

5. It’s not about physician greed. These findings suggest that it is not greed that is driving physicians to order unnecessary tests and procedures. After all, physicians kept ordering those tests even for patients who probably wouldn’t be able to pay for them.

But don’t dismiss the role of financial incentives. Another study showed that hospital-based physician groups order more unnecessary services than community-based practices. These findings hint at the likelihood that hospitals’ financial interests influence physician behaviors. Health care providers are under tremendous financial pressure. Eliminating wasteful care would put lots of people out of business. It is naive to think that the 20% rate of unnecessary care has nothing to do with financial interests.

We have an epidemic of unnecessary care in the U.S. Giving patients a financial stake in their healthcare — exposing them to more out-of-pocket costs — isn’t likely to be a quick cure for this problem. Solutions to prevent unnecessary medical care should primarily focus on helping physicians change their habits (instead of giving patients more skin-in-the-game).

https://bit.ly/2wkEdcq

Allergan (AGN) Receives CRL from FDA for fibroid med application

Allergan plc (NYSE: AGN) today announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) in response to the New Drug Application (NDA) for ulipristal acetate (UPA) for the treatment of abnormal uterine bleeding in women with uterine fibroids.

The letter from the FDA indicates it is not able to approve the ulipristal acetate NDA in its current form and is requesting additional information. The agency cited safety concerns regarding ESMYA post-marketing reports outside the United States. Allergan plans to meet with the FDA to discuss their comments and next steps.

“Allergan continues to believe in the need for novel treatment options for women who are looking for a non-surgical treatment for uterine fibroids,” said David Nicholson, Chief Research and Development Officer, Allergan. “We intend to meet with the FDA to discuss the Complete Response Letter and determine the potential next steps for our ulipristal acetate NDA.”

The New Drug Application for ulipristal acetate included the results of a robust clinical trial program which included two U.S. Phase 3 clinical trials and all Phase 3 EU registration studies as well as real-world data in more than 700,000 women with uterine fibroids across 80 countries worldwide.

https://bit.ly/2w1FAO7

Employers offering more cancer benefits but need to be sure employees use them

As they make more cancer benefits available to their employees than ever, large employers need to consider offering more help to workers who have been diagnosed with cancer to navigate the maze of options.

On Tuesday, the Northeast Business Group on Health released a guide to help employers do just that.

“Many employers have a variety of vendors and other people internally who can provide health to someone with a cancer diagnosis,” said Candice Sherman, the CEO of NEBGH.

With a “constellation” of different offerings from those vendors, newly diagnosed patients can find themselves fielding calls from different companies including their health plan, a second opinion service, a disability manager, navigation services and wellness coaches. “And a newly diagnosed cancer patient likely isn’t in the best of all minds to sit down and figure out all the options that are available to them,” Sherman said.

One of the most important ways companies can handle this? Introduce their vendors to each other.

This is crucial “so they know what the other does and can more seamlessly work together,” Sherman said.

The National Business Group on Health recently released 2019 projections as part of their annual survey of large employers which found companies expect the total cost of providing medical and pharmacy benefits will rise 5% for the sixth consecutive year next year, reaching an average cost of $14,800 in 2019.

Cancer can be a major driver of cost. The NBGH estimates while less than 1% of members in a typical commercial population have claims for cancer in a given year, the claims account for about 10% of all medical costs. Cancer has been the leading cause of long-term disability for nearly a decade and employees often have high rates of absenteeism in the course of their treatment for services like chemotherapy and lab visits. Plus, treatment side effects may compromise their ability to perform day-to-day duties.

Cancer patients could benefit from resources that are already available to them to navigate the fast evolving landscape of cancer care to avoid unnecessary tests and treatments.

“One of the things our members have said is: ‘Look, we want to provide the best possible care to our employees and their families and we want to get value from those dollars we’re spending,'” Sherman said.

The guide offers employers ideas about how to create a “huddle” with a designated “quarterback” to coordinate employee and family medical benefits along with social and emotional support services. It’s also meant to ensure employees or their family members are not left confused by their benefits or simply exasperated by multiple contacts asking for the same pieces of information.

It isn’t meant to replace regular coordinated communication above benefits to employees before they get sick, Sherman said.

But establishing better processes once a patient is diagnosed can help ensure benefits are put to their best use by ensuring their employees know not only about support for their clinical care, but also services to help them through the emotional fallout and financial toxicity that a cancer diagnosis can wreak, she said.

https://bit.ly/2wggDxy

Federal appeals court calls for redo of $1.4B tax ruling in Medtronic’s favor

A federal appeals court has thrown out a previous tax court ruling favoring Medtronic on procedural grounds, reigniting a years-long dispute with the IRS over the payment of nearly $1.36 billion in back taxes.

Initially, the IRS took issue with Medtronic’s allocations of incomes between its subsidiaries through royalties and licensing agreements. Using methods such as transfer pricing, the IRS said the medtech giant shifted too much of its profits to its Puerto Rican subsidiary in an attempt to avoid a higher rate.

Though part of the U.S., Puerto Rico is considered international for tax purposes, with the IRS describing the move as a “classic case” of companies trying to move profits offshore. Medtronic has since moved to Ireland, following its $50 billion merger with Covidien.

The agency had first demanded payments of $548 million and $810 million in missed federal taxes for 2005 and 2006, respectively, but a ruling in the IRS’ favor could open the company up to billions more in taxes from the following years—not to mention other transnational companies using similar accounting methods.

The U.S. Tax Court, however, had called the IRS’ calculations “arbitrary, capricious or unreasonable,” and rejected both the federal government’s and Medtronic’s methods for determining the proper tax amount before conducting its own analysis in 2016. It later concluded Medtronic owed $26.7 million for 2005, but had overpaid its 2006 taxes by $12.5 million. The IRS appealed.

In its opinion (PDF), the Eighth Circuit Court of Appeals said the lower tax court would need to revisit the case after failing to address a variety of circumstances, including the amount of risk and product liability expenses that should be allocated in the devicemaker’s licensing arrangements between its companies.

The IRS contended that Medtronic Puerto Rico bore only 11% of the device manufacturing costs, including product liability expenses, and its allocation of profits should be similar. But the tax court said that did not give enough weight to the risks incurred in ensuring quality.

The tax court ended up allocating almost 50% of the company’s device profits to the island subsidiary—but the appeals court said those conclusions were reached without specifically detailing amounts of risk and liability expenses, and would need to be reevaluated.

https://bit.ly/2Mt0QGs

FDA Clears SPR Therapeutics’ Non-Opioid Neurostimulation Pain Therapies

The U.S. Food and Drug Administration (FDA) cleared Cleveland-based SPR Therapeutics’SPRING endura (single lead) and extensa (dual lead) Peripheral Nerve Stimulation (PNS) Systems for controlling pain.

The SPRING System is the only percutaneous PNS System cleared by the agency and is indicated for up to 60 days in the back and/or extremities for chronic and acute pain. It is the only dual lead capable PNS platform in the industry.

Peripheral nerve stimulation (PNS) delivers rapid electrical pulses, which are described as feeling like mild tingling. Common usage is for certain complex regional pain syndrome, peripheral nerve injuries, back pain, occipital nerve stimulation for the treatment of migraine headaches, and others.

The system uses a “MicroLead” delivered by way of a 20-gauge introducer. One end is connected to a wearable controller device. The MicroLead has a barbed anchor that holds it in place, but a highly flexible coil of the lead allows the patient freedom of movement.

Physicians are able to implant two leads connected to a single wearable pulse generator during an outpatient procedure. It has rechargeable batteries and a Bluetooth-enabled controller.

The idea is that it can be used to treat pain without pain medications, which hopefully will prevent the addiction so common with opioids. Preliminary results from a SPRINT clinical trial for the treatment of chronic postamputation pain has early data showing significant decreases in pain or pain interference in two-thirds of patients after the 8-week treatment period. Longer-term pain relief was seen in four out of five patients who completed the entire 12- month trial.

“Our SPRINT PNS platform is designed to deliver the least invasive and most user-friendly PNS therapy experience for physicians and their patients,” said Maria Bennett, SPR Therapeutics’ founder, president and chief executive officer, in a statement. “With the ease of use and dual lead capabilities we’ve built into the SPRINT System we look forward to advancing the early use of neurostimulation as a non-opioid alternative for more patients while we continue to generate data that demonstrate significant and sustained pain relief following our 60-day therapy.”

The device received a 510(k) approval. It is classified by the FDA as a percutaneous electrical nerve stimulator (PENS), somewhat different than what the PNS name would suggest. The FDA classifies PNS as intended for long-term implantation within the body, while this system is designed for shorter outpatient procedures.

In September 2018, SPR Therapeutics closed on a $25 million Series C financing led by Frontcourt Ventures. It has also received a total of $9 million in contracts from the U.S.Department of Defense. The primary competition in the marketplace is NeuroMetrix’s Quell.

“The SPRINT PNS system provides a non-opioid therapy alternative that we have used successfully with many of our pain patients,” said interventional pain management physician Chris Gilmore, of Carolinas Pain Institute in Winston-Salem, North Carolina, in a statement. “In my experience, most patients prefer a non-permanent, non-destructive and non-surgical option for pain management when possible. The minimally invasive nature of the SPRINT System allows us to introduce peripheral nerve stimulation therapy early in the care continuum, including its use in well-selected patients with back pain.”

https://bit.ly/2Bz06uy

Massive Study Reveals Secrets About the Aging Brain

Researchers from Amen Clinics in Costa Mesa, California, Google, John’s Hopkins University, University of California, Los Angeles and the University of California, San Francisco studied62,454 brain scans of more than 30,000 people to study brain aging.

The brain scans were SPECT (single photon emission computed tomography) scans. The people who participated ranged in age from 9 months to 105 years of age. SPECT tomography reveals regional cerebral blood flow that is reduced in various disorders.

“Based on one of the largest brain imaging studies ever done, we can now track common disorders and behaviors that prematurely age the brain,” said Daniel Amen, founder of Amen Clinics and lead author of the study, in a statement. “Better treatment of these disorders can slow or even halt the process of brain aging. The cannabis abuse finding was especially important, as our culture is starting to see marijuana as an innocuous substance. This study should give us pause about it.”

The study participants also displayed various psychiatric disorders, including bipolar disorder, schizophrenia and attention deficit hyperactivity disorder (ADHD). The study looked at 128 brain regions and attempted to predict the chronological age of the patient. If the scan prediction suggested the patient was older than their actual chronological age, this was interpreted as accelerated brain aging.

Several brain disorders and behaviors predicted accelerated aging. For example, schizophrenia showed an average of 4 years of premature aging. Cannabis abuse showed 2.8 years accelerated aging. Bipolar disorder showed 1.6 years accelerated aging. ADHD showed 1.4 years accelerated aging, and alcohol abuse showed 0.6 years accelerated aging.

One unexpected finding was that depression did not appear to cause accelerated brain aging—and neither did aging.

The study, “Patterns of Regional Cerebral Blood Flow as a Function of Age Throughout the Lifespan” was published in the Journal of Alzheimer’s Disease.

“This is one of the first population-based imaging studies, and these large studies are essential to answer how to maintain brain structure and function during aging,” said George Perry, chief scientist at the Brain Health Consortium from the University of Texas at San Antonio, in a statement. “The effect of modifiable and non-modifiable factors of brain aging will further guide advice to maintain cognitive function.”

The study comes out at the same time as research from MIT’s Picower Institute for Learning and Memory, which suggests that a decrease in the plasticity of specific neurons may be the fundamental cause of normal age-related cognitive decline.

The MIT study tracked the growth and structure of inhibitory interneurons in mice as they aged. The initial data showed no significant drop in the number of inhibitory brain cells as the mice aged. What did show up, however, was a drop in plasticity markers starting around the age of six months, which is considered about middle-aged in mice. (Mice typically live 24 months. Three months is considered mature, 18 months is a senior citizen.)

Between the ages of three and 18 months, the dendrites, the branches that connect neurons, progressively slowed. The researchers wrote in a statement, “Despite common belief, loss of neurons due to cell death is quite limited during normal aging and unlikely to account for age-related functional impairments. Rather, it seems that structural alterations in neuronal morphology and synaptic connections are features most consistently correlated with brain age and may be considered as the potential physical basis for the age-related decline.”

The researchers were able to reverse the aging using fluoxetine, an antidepressant sold under the brand names Prozac and Sarafem. The problem from a practical point of view is these antidepressants aren’t recommended for use in the elderly because of side effects and would have to be administered starting at a young age. However, the fact that it was reversible in laboratory animals shows promise for future research.

The article was published in the Journal of Neuroscience.

https://bit.ly/2OUJgIh