This simple test detects C-reactive protein (CRP), a blood marker of inflammation and bacterial infections, and resulted in 20% fewer patients using antibiotics for acute exacerbations in the trial.
Importantly, patients’ reduced use of antibiotics seemed safe, without negative effects on recovery. Safely lowering reliance on antibiotics may also contribute to lesser resistance to these medications.
COPD patients often experience exacerbations, or flare-ups, and when this happens, three out of four are prescribed antibiotics. But use of this medication often offers no benefit, because about two-thirds of the flares are not caused by bacterial infections.
“Governments, commissioners, clinicians, and patients living with COPD around the world are urgently seeking tools to help them know when it is safe to withhold antibiotics and focus on treating flare-ups with other treatments,” Nick Francis, PhD, a professor at Cardiff University and the study’s senior author, said in a press release.
Researchers investigated if a simple point-of-care blood test could help doctors decide whether to prescribe antibiotics to patients with COPD flares. They developed a finger-prick test that measures the amount of CRP — a marker of inflammation that rises rapidly in the blood in response to inflammatory conditions, including bacterial infections.
The idea was that people with a COPD flare and a low CRP level likely would not have an airway infection caused by bacteria, and thus would benefit little from taking antibiotics.
To determine their test’s value, the team ran an open-label trial called PACE (ISRCTN24346473), which enrolled 653 COPD patients who consulted a doctor at centers in England and Wales for an acute exacerbation. Participants were randomly assigned to either usual care guided by a CRP finger-prick test, or usual care alone.
Results showed that fewer patients taking the test used antibiotics, compared with the usual care group (57.0% vs. 77.4%). But this did not seem to happen at the expense of patient’s well-being and quality of care.
Two weeks after the consultation, the test-guided group scored better in health-related quality of life as measured by the clinical COPD questionnaire. Likewise, patients reported no negative effect on their well-being or use of healthcare services over the following six months.
“Most antibiotics are prescribed in primary medical care, and many of these prescriptions do not benefit patients: point of care testing is being vigorously promoted as a critical solution for better targeted antibiotic prescribing. However, there have been virtually no trials of point of care tests that measure impact on clinician behavior, patient behavior, and patient outcomes,” Chris Butler, a professor at University of Oxford and the study’s lead author, said.
“Ours is the first trial of biomarker guided management of AECOPD [acute exacerbations in COPD] in ambulatory care, and has found an effect that should be practice-changing,” Butler noted.
According to Francis, the finger-prick blood test assessing CRP was “able to achieve a reduction in antibiotic use that is about twice the magnitude of that achieved by most other antimicrobial stewardship interventions, and demonstrate that this approach was safe.”
“CRP-guided prescribing of antibiotics for exacerbations of COPD in primary care clinics resulted in a lower percentage of patients who reported antibiotic use and who received antibiotic prescriptions from clinicians, with no evidence of harm,” the study concluded.
Jonathan Bidmead, a patient in the PACE study, added that many people are indeed saved by antibiotics, “but also that many are harmed though unnecessary antibiotic use.”
Long-term use of low-dose macrolide antibiotics is safe and potentially effective in reducing acute exacerbations in younger patients with chronic obstructive pulmonary disease (COPD) who are at risk for poorer outcomes, a review study suggests.
Although this therapeutic regimen was found to be generally well-tolerated, with few side effects, it was found to be unsuitable for elderly patients, the researchers said. Additional studies are therefore warranted to further explore the long-term effects of macrolides in the COPD population.
These compounds have also been shown to exert broad-ranging immunomodulatory and anti-inflammatory effects, in addition to their antibiotic properties.
Frequent acute exacerbations are a well-known risk factor for deteriorating respiratory function among patients with COPD. In fact, estimates indicate that approximately half of COPD treatment costs are to manage and resolve acute exacerbations.
About 50% of acute exacerbations in COPD patients are triggered by lung bacterial infections, and are accompanied by airway inflammation. Given the immune- and inflammation-mediated nature of these events, macrolides have been viewed as potential agents to target COPD acute exacerbations. However, when tested in clinical trials, these compounds have failed to demonstrate significant benefits, so their use is not generally accepted for COPD.
To investigate the impact of macrolides on COPD exacerbations, researchers in China reviewed clinical data from 10 previously published studies about the use of these antibiotics. Their analysis included a total of 1,521 COPD patients treated with macrolides, and 1,418 who were not (control group).
Results showed that, compared with a placebo, treatment with macrolide antibiotics could reduce the risk of exacerbations by 23% in COPD patients.
Also, data collected from 1,415 participants (in seven of the studies analyzed) showed that prophylactic use of macrolide could prolong remission time.
“Our meta-analysis has analyzed and confirmed that long-term low dose usage of macrolides could significantly reduce the frequency of the acute exacerbation of COPD,” the researchers wrote.
These findings were confirmed with additional data from nine studies (involving 1,508 patients), which showed that the rate of exacerbations per patient per year was significantly reduced among patients treated with macrolides. Also, the mean number of hospitalizations due to exacerbations was reduced in macrolide-treated patients, according to data from four of the studies.
Erythromycin seemed to be the most effective of the macrolides analyzed in reducing exacerbations, the study suggested.
Macrolide antibiotics were generally safe and well-tolerated in the patients, with the most common adverse events being gastrointestinal reactions, and cardiovascular events. A side effect reported with azithromycin use was hearing impairment.
However, the researchers found that older COPD patients were less likely to respond to treatment with macrolides.
Overall, “long-term low dose usage of macrolides could significantly reduce the frequency of the acute exacerbation of COPD,” the researchers wrote, adding that the “treatment was well tolerated, with few adverse reactions, but it was not suitable for the elderly.”
According to the team, macrolides should be used in younger COPD patients with a “higher risk of acute exacerbation and mortality.”
The team also emphasized that further studies are needed “in order to obtain more comprehensive and objective conclusions on the efficacy of macrolide antibiotics in the treatment of stable COPD.”
Scientists have found data to support an optimal threshold for lung function that can accurately diagnose clinically significant airflow obstruction and chronic obstructive pulmonary disease (COPD).
Using information from adults across the U.S., researchers found that a 70% ratio of two spirometry indicators of lung function proved as good, or even better, than other used thresholds for predicting COPD-related hospitalizations and deaths.
The work, funded by the National Institutes of Health (NIH)’s National Heart, Lung, and Blood Institute, builds upon multiethnic studies, validates current guidelines from major respiratory societies, and contributes to identifying a fixed threshold of disease severity.
“The currently used criteria are based on expert opinion, and until these results were published, there was not enough evidence to support their use,” Bhatt added.
Doctors use spirometry tests, which measure the rate of air flow and estimate lung volume, to monitor lung function and evaluate the severity of lung disease. Several indicators can be taken from these tests, including how much air a person can exhale in the first second during a forced breath (FEV1, forced expiratory volume) or the full amount of air a person can exhale forcefully (FVC, forced vital capacity).
FEV1 and FVC values are usually proportional, and lower ratios are seen in individuals with obstructive lung diseases, such as asthma or COPD.
Major respiratory society guidelines recommend diagnosing airflow obstruction when the ratio of FEV1/FVC is lower than a fixed value of 0.70. This means that a healthy individual should breath out at least 70% of their lung volume, or vital capacity, in the first second during a forced exhalation followed by a maximal inhalation.
However, there is no rigorous, data-based evidence to support this threshold, which had been set by expert opinion.
“The selection of a threshold for defining airflow obstruction has major implications for patient care and public health, as the prevalence of the condition could vary by more than a third depending on the metric used,” Elizabeth C. Oelsner, MD, assistant professor at Columbia University and senior author of the study, said in a NIH release.
In the study, researchers aimed to determine how accurate several used thresholds were in predicting COPD outcomes.
They analyzed spirometry data and COPD-related clinical events in 24,207 adults of different ethnic backgrounds, pooled from four U.S. population-based studies: 54% were women, 69% were white, and 24% were black. The participants, from 45 to 102 years old, were enrolled from 1987 to 2000, and followed through 2016. Complete follow-up was available for 11, 077 participants (77%) at 15 years.
Results showed that the currently used FEV1/FVC ratio of 0.70 was the optimal fixed threshold to predict COPD-related hospitalization and mortality, and this was as good or even more accurate than other used thresholds, including the lower limit of normal, which draws normal values of lung function from reference populations.
“These results support the use of FEV1/FVC less than 0.70 to identify individuals at risk of clinically significant COPD,” the researchers wrote.
“The ongoing disagreement between experts on the best spirometry criteria to diagnose airflow obstruction has resulted in a lack of clarity for clinicians. Using a simple standard threshold has the potential to improve the diagnosis and treatment of this common disease,” Bhatt concluded.
Approximately 16 million Americans have COPD, but it is estimated that millions more have the disease but have not been diagnosed, according to the NIH.
However, to date, no study had analyzed the full extent of bone fracture risk associated with COPD.
A group led by researchers at the University of Nottingham set out to investigate the incidence of hip fractures and all major osteoporotic fractures (MOF), as well as the prevalence of osteoporosis in patients with and without COPD.
The cohort-based study gathered medical records on 80,874 people with COPD, and 308,999 other patients with different diseases that had been stored at The Health Improvement Network (THIN), a large anonymized database containing electronic records representing approximately 6.2% of the entire U.K. population, from 2004 through 2015. All were age 40 or older; diseases in the non-COPD group were not specified.
Clinical data, demographics, medication use, incidence of osteoporosis, history of falls, and bone fractures were analyzed in all patients. Hip fractures and all major fractures (including hip, lower and upper arm bones, and vertebrae fractures) were assessed.
Two different fracture risk prediction tools — the FRAX and the QFracture tools — were used to estimate the risk of fractures in COPD patients.
Results showed that COPD patients had a higher prevalence of osteoporosis compared to non-COPD patients, 5.7% versus 3.9% respectively.
People with COPD also had an increased risk of both hip fractures alone (1.67 times higher) and all major osteoporotic fractures (1.60 times higher) than other patients.
Both FRAX and QFracture tools had a similar discriminatory accuracy for hip fractures (76.1%) in COPD patients. However, FRAX had a slightly better accuracy for MOF fractures (71.4%) compared to QFracture (61.4%).
According to FRAX scores, 29,035 (40%) COPD patients had a risk equal or greater than 3% of experiencing a hip fracture, while 6,221 (8.6%) had a risk equal or higher than 20% of any MOF. QFracture scores led to similar results, with 33,065 (45.6%) at 3% or greater risk of hip fractures and 9,546 (13.2%) at 20% or greater risk of any major osteoporotic fracture.
As such, the researchers reported “an increased risk of fractures and osteoporosis,” which could be attributed to several factors, including the use of oral corticosteroids, patients’ body mass index (BMI), physical activity levels, and smoking habits.
“The identification with a systematic assessment of bone health and addressing prevention and treatment of those at a greater risk of fracture have the potential to improve outcomes for patients with COPD,” the researchers concluded, adding that tools like FRAX can help in identifying COPD patients at high risk of fracture.
This makes Japan the first country to grant regulatory approval for Breztri Aerosphere.
Breztri Aerosphere, which is composed of budesonide, glycopyrronium and formoterol fumarate, is also the first triple combination therapy contained in a pressurized metered-dose inhaler to be granted approval by the Japanese Ministry of Health, Labour and Welfare.
“Chronic obstructive pulmonary disease affects more than five million people in Japan, and Breztri Aerosphere offers these patients a new, powerful triple-combination therapy in a pressurized metered-dose inhaler,” Mene Pangalos, executive vice president of biopharmaceuticals research and development at AstraZeneca, said in a press release.
“This first approval of Breztri Aerosphere is a significant step towards providing a new treatment choice to people living with chronic obstructive pulmonary disease globally,” he added.
Approval was based on positive results from the Phase 3 KRONOS trial (NCT02497001) which showed that Breztri Aerosphere could lead to significant improvement in COPD patients’ respiratory function — determined by changes in forced expiratory volume in one second (FEV1) — in comparison with the company’s dual combination therapies Bevespi Aerosphere (composed of glycopyrronium/formoterol fumarate) and PT009 (composed of budesonide/formoterol fumarate).
Treatment with Breztri Aerosphere also led to a significant 52% decrease in the rate of moderate or severe COPD exacerbations (acute worsening events) compared with approved therapy Bevespi Aerosphere.
“The KRONOS trial demonstrated that Breztri Aerosphere provides rapid and sustained, clinically-relevant lung function improvements in patients with moderate to very severe chronic obstructive pulmonary disease,” said Klaus Rabe, professor of pulmonary medicine at the University of Kiel in Germany and national coordinating investigator of the KRONOS trial. “Triple-combination therapy is an increasingly important treatment option and will play a central role in helping patients manage their disease.”
The agreement could make Yupelri available in the future to the nearly 100 million COPD patients living in China, where 43% have moderate to severe forms of the disease, and COPD is in one of the three top causes of death.
Under the deal, Theravance Biopharma has granted Mylan exclusive rights for developing and selling Yupelri in China and adjacent territories, including Hong Kong, Macau, and Taiwan. In turn, Theravance Biopharma is paid $18.5 million and remains eligible for additional payments and royalties on net sales, if the product is approved.
“We are pleased to expand our ongoing revefenacin development and commercialization collaboration with Mylan to include China, as we believe that this novel compound has the therapeutic profile to provide key benefits to the country’s large and underserved COPD patient population,” Rick E. Winningham, chairman and CEO of Theravance Biopharma, said in a press release.
“Our companies share the belief that revefenacin can play a critical role in COPD treatment, particularly for those patients who require or prefer nebulized therapy,” he said.
Yupelri is a long-acting muscarinic antagonist (LAMA) administered once daily via a nebulizer and indicated for the maintenance treatment of adults with COPD. It acts as an anticholinergic bronchodilator to help keep the bronchial muscles in the lungs relaxed to prevent symptoms such as wheezing, coughing, chest tightness, and shortness of breath. The medicine is intended for COPD patients who require, or prefer, nebulized therapy.
Pill and liquid versions of LAMAs were available before Yupelri’s approval in the U.S. in 2018, when it became the first approved LAMA to be delivered as a mist, compatible with common nebulizers.
The stability of revefenacin, Yupelri’s active ingredient, in both metered dose inhaler and dry powder formulations also suggests the medicine could work in novel handheld combination products, Mylan said.
“Mylan has had a long-term, strategic focus on its growing presence in China, one of the world’s largest pharmaceutical markets,” said Rajiv Malik, president of Mylan. “Our expanded partnership on revefenacin represents a natural next step, and together with Theravance Biopharma we look forward to making a meaningful difference for the millions of patients living with COPD in China.”
People with COPD are often prescribed inhalers, but — like with any medication — it is virtually impossible for a physician to know if patients takes their medication as regularly or as often as prescribed.
“We prescribe inhaled medications for patients with COPD all the time,” Umur Hatipoğlu, MD, a pulmonologist at Cleveland Clinic and co-author of the study, said in a press release.
“It’s really the cornerstone of their therapy, and when they return to the clinic we do ask them whether they’re using their medications, but the reality is we never know how adherent patients are objectively,” Hatipoğlu said.
Researchers hypothesized that if physicians could know, with certainty, how often patients takes their meds, it might reduce the need for more intensive healthcare, like hospitalizations or emergency room visits.
To find out, investigators recruited 39 people with COPD who had been hospitalized at least once in the year preceding the study. Participants were given an electronic monitoring device, provided by the company Propeller Health, which connected to their inhalers.
The monitoring devices then sent information — primarily usage data — to the patients’ phones. This allowed participants to receive alerts when they were using their inhalers less often than advisable — and, therefore, when they were at a higher risk of worsening symptoms. Alerts also were sent to the doctors managing the patient, allowing them to keep informed of medication use in real time.
Electronic monitoring was done for 280.5 days on average — a little more than nine months.
In the year before the study, participants averaged 3.4 hospital visits per year. Following electronic monitoring, this rate decreased to 2.2 visits per year, a statistically significant decrease.
There also was a trend toward patients using fewer healthcare resources after the implementation of electronic monitoring. However, this trend did not quite reach statistical significance, meaning the researchers could not rule out the possibility that this change was just due to chance.
Still, according to the team, the results suggest that electronic monitoring of inhaler usage might decrease the need for hospitalization in people with COPD.
Electronic monitoring “in conjunction with a disease management program may play a role in reducing healthcare utilization in COPD patients with a history of high healthcare utilization,” the researchers concluded.
“Electronic inhaler monitoring allows us to assess inhaler adherence at the point of care,” Hatipoğlu concluded.
Note: This is the second article in a three-part series written in collaboration with respiratory therapist Mark W. Mangus Sr., RRT, RPFT, FAARC, and oxygen expert Ryan Diesem. The first part can be found here.
When it comes to home improvement, people typically want three things from a contractor: good, fast, and cheap. Under all but the most rigorous (and lucky) circumstances, you can choose any two of the three. What this means is that you can have it good and fast, but chances are, it’s gonna cost you an arm and a leg. And while you may be able to get it fast and cheap, I can assure you that it probably won’t be that good. Or you may also be able to get it good and cheap, but it’s not gonna be fast. This could be why we can never get in touch with our contractor (once they have your deposit, of course).
There is a similar scenario occurring in the world of supplemental oxygen. People want three things. They want a delivery system that will be small and lightweight. They want a system that will last a long time. And they want a system that will provide a high liter flow, AKA a lot of oxygen.
Well, guess what? You can choose any two. What this means is you can have a system that is lightweight and long- (or more likely, medium-) lasting, but it’s not going to give you much oxygen. You can have a system that is lightweight and delivers a lot (or at least a moderate amount) of oxygen, but it’s not going to last very long. Or you can have a system that gives you a fair amount of oxygen and lasts for a fair amount of time, but it definitely won’t be light.
I tell you these things (as I have for more than two decades) not to scare you nor for the sole purpose of putting the oxygen companies on blast (although many of them definitely need to be on blast). I tell you these things because I think it’s important for you to understand that the medical oxygen system is rigged, and not in your favor. And the systems themselves can be very confusing, even for many clinicians.
It also involves money, and as you know, often when a situation involves money, that’s when a lot of wolves — whose primary objective is to line their own pockets — come out in sheep’s clothing. Well, think of me as Little Red Riding Hood here to help you see the wolf for who he or she really is and to help you get the best oxygen delivery system for you.
It’s sort of like the Seinfeld episode where Kramer comes up with a coffee table book about coffee tables. Well, it’s sad to say, but we need a better supplemental oxygen system for supplemental oxygen systems.
Recently, I received a phone call from a longtime patient named Mrs. M., inquiring about a new portable oxygen concentrator (POC) she was planning to buy with her own money. She was told by one of the company’s sales agents that the device could provide up to 6 liters per minute (lpm) of oxygen. I assured Mrs. M. that this could not possibly be true because no POC exists that is capable of delivering 6 lpm. She was sure this was what the representative told her, so I asked her to have them call me.
I soon received a phone call from that person’s sales manager, who finally and reluctantly conceded that the numbers were actually manufacturer’s settings, not liters per minute. I wondered to myself if this was in fact a light bulb moment for him.
We eventually agreed that on a setting of six, the device would provide 1,260 ml of oxygen (1.26 liters) per minute, which I stated would not be enough for Mrs. M.
To be clear, Mrs. M. has been my patient for a very long time, and I have been a cardiopulmonary physical therapist for a very long time (27-plus years). So, when I stated that the POC in question would not meet my patient’s needs, I wasn’t telling the gentleman what I think. I was telling him what I know.
He then went on to oxygen-splain that that was why there was a 30-day money-back guarantee. Ohhh. We also discussed the “re-stocking fee,” which he assured me would be waived if the machine did not meet Ms. M.’s needs. How generous (yes, while I know you probably find this hard to believe, I am being sarcastic).
Well, guess what? The following week, I tested the device with my patient, and sure enough, it didn’t even come close to meeting her needs (as I knew damn well it wouldn’t).
So now my patient is in the uncomfortable position of having to return the device and, as you can imagine, deeply disillusioned because she was promised a rose garden full of lightweight oxygen that loves you long time.
But there is something even more important that should be considered. We are talking about supplemental oxygen, not a non-stick frying pan, not a mattress, and not a prom dress; oxygen: a crucial life-sustaining substance, without which people can get hurt or die.
Think of it like a parachute or the air bag in your car. If they don’t actually do what they are supposed to do in the way they are supposed to do it, well, that 30-day money-back guarantee really won’t be of much use, will it?
It is for all of these reasons that my goal is now, as it has always been, to help you gain the greatest understanding of your oxygen requirements, as well as how to ensure that these requirements will be met, so you can truly get the best system for you and use it to your maximal advantage. I will explain these concepts using simple terms and descriptions, leaving out the scientific mumbo-jumbo you don’t need to know in order to choose your best device.
The rest of this piece will be composed of concepts that every prospective oxygen user should understand, and you can put them in the bank like money, meaning they are definitely correct. If you don’t believe me, you can ask Mark Mangus. If you don’t believe Mark, you can ask Ryan Diesem. If you don’t believe any of us three, well then just stop reading now because there’s really no hope for you. OK. Here we go.
Oxygen by any other name …
Oxygen can come in one of three basic forms. It can come as a gas, as in a metal tank or cylinder; it can come from a concentrator, which can either be stationary, as in those plug-in home models, or portable (POC); or it can come as a liquid. There are upsides and downsides to each one of these delivery methods, and often, it comes down (or should come down) to making the best choice for you (or availability, as is the case of liquid oxygen, which I will discuss at the end).
As a general rule, oxygen coming from a tank will be purer than that coming from a stationary concentrator, meaning that 2 (or 3 or 4) lpm from a tank will have a slightly to more than slightly higher percentage of oxygen. In the case of most tanks, this should be 100% medical-grade oxygen and, depending upon the regulator used, can go as high as 25 lpm. When it comes to the home stationary plug-in units, some can go as high as 10 lpm, just slightly less pure than the tanks.
It also means that 3 lpm on a tank will likely keep you slightly (or somewhat more than slightly) more saturated than 3 lpm on a stationary concentrator, and although they are supposed to be equal, I can assure you they are not. This is why your oxygen saturation is so much higher on that big, beautiful, green and silver tank you use at rehab compared with your shorter, squatter (think R2-D2), slightly less beautiful concentrator sitting in your living room.
This brings me to my next point, which is why I used 3 lpm as my example. At this moment in time, 3 lpm is the maximum amount of oxygen that can be delivered continuously by any POC. Period.
While this may not be what you want to hear, it is what you need to hear so that if a sales rep tries to tell you that their unit goes up to 6 lpm, you can say without a doubt that 6 refers to a manufacturer’s setting, and not liters per minute. Any higher number than 3 definitely refers to a manufacturer setting that definitely corresponds to a substantially lower liter flow.
At this moment, liquid oxygen provides the closest we can get to having all three wishes granted by the same unit, in that it’s lightweight, has a long duration, and provides high continuous liter flows. In fact, for those reasons, I think a great name for these units would be The Genie. The problem is, for most people, genies don’t really exist.
Due to a lack of adequate reimbursement from the Center for Medicare and Medicaid Services (CMS) and other third-party payers, liquid oxygen has become increasingly difficult for suppliers to provide and, consequently, nearly impossible for many patients to obtain. I am currently working with a team on a new product and a system that will hopefully solve this problem, but it is also crucial for patient advocacy groups to keep the pressure on Washington.
There are other important factors that would be helpful for you to know about liquid oxygen, but I prefer to address those as an independent subject. Yes, it’s that important.
Continuous Versus Pulsed Delivery
As the names imply, continuous oxygen is delivered continuously, meaning it is always flowing. Pulsed-dose oxygen will provide intermittent bursts of oxygen, typically triggered by breathing in through the nose.
All three forms of oxygen (tanks, concentrators, and liquid) can potentially provide both continuous and pulsed oxygen depending upon the device and the accessory equipment used, and if you think about why this is so, it should make perfect sense.
Tanks can run continuously or with the help of a conserving-type regulator. They vary in size and weight, and have the ability to provide high (or at least moderate) liter flows. These two factors will determine how long they will last. In other words, the larger the tank, the longer it will last. The higher the liter flow, the shorter it will last.
Home (plugin) concentrators are able to provide high liter flows (up to 10 lpm on some models) due to the increased size and number of sieve beds, the filter that separates the nitrogen from the oxygen in the air. In addition, they don’t have the same time constraints as portable units since they run on AC electricity as opposed to a battery. As such, they are neither small, lightweight, nor are they very portable, although most are on wheels so you can move them around the house more easily. Two scenarios you need to be prepared for would be either equipment malfunction or a power outage. So if you do rely on a home concentrator, please make sure you have a few tanks on hand as a backup.
The single best source I have found related to portable oxygen concentrators, particular the actual devices themselves, is the Pulmonary Paper’s annual Portable Oxygen Concentrator Guide, written by oxygen super-guru and soon-to-be-respiratory-therapist Ryan Diesem. The guide provides excellent descriptions, as well as specifications, for the vast majority, if not all, available units.
While my goal is never to reinvent the wheel, there are a few points I want to make that will help you use the guide to your maximum advantage in deciding which unit to buy (or not to buy) –Will Shakespeare.
When comparing POCs with one another and with other delivery systems, be sure to check the maximum oxygen production in milliliters (ml) per minute. If you divide this number by 1,000, you will get the maximum amount of oxygen that the unit can produce in liters per minute. As an example, a unit that can produce 3,000 ml per minute produces 3 lpm, regardless of the number of settings it has. A device that produces 1,050 ml per minute provides 1.05 lpm, and a unit that produces 680 ml produces 0.68 lpm, not even 1 lpm. How is that for perspective? For the 2019 guide, Ryan even did the math for you, which is a super-valuable addition.
So, if you require 6 lpm with a non-rebreather mask to stay saturated during your pulmonary rehab sessions, it is highly unlikely that one of these units will meet your needs. In the case of Mrs. M., even though the unit had six settings, the maximum oxygen delivered was still only 3 lpm, which is one of the reasons why it couldn’t keep her saturated unless she was at rest (which sort of defeats the purpose of a portable unit). We will discuss some of the other reasons in the next installment.
All the above commentary assumes that all other factors are created equal and that they all take place in an ideal world, neither of which is usually the case. For this reason, it is crucial for you to understand the other factors that will either make your device more or less acceptable to you and how to get the maximum effectiveness and greatest bang for your buck, regardless of manufacturer, unit, or delivery method.
These include factors such as whether you use a nasal cannula versus a mask, as well as using the correct breathing techniques to ensure the oxygen makes it into your lungs, regardless of the delivery device. These factors will be discussed next month in the third and final installment of the “Oxygen Manifesto,” along with this piece and “Oxygen Manifesto Part 1.”
Below is an excerpt from a letter I wrote to an unnamed POC supplier on behalf of my patient. I share this (with Mrs. M.’s permission) to help you to navigate the system more effectively and to help you hold companies more accountable.
To whom it may concern:
Recently, I received a phone call from my longtime patient, Mrs. M. inquiring about your new [insert company and model number here]. She was told by one of your sales agents that the [model] provides up to 6 liters per minute of oxygen. I assured Mrs. M. that this could not possibly be true because there is no POC capable of delivering 6 liters per minute. …
I then spoke with a manager at your company who began the conversation by stating that the [model] goes up to 6 liters per minute before acquiescing that the numbers were manufacturer’s settings and not actually liters per minute. …
We eventually agreed that the (model) on setting 6 would provide 1,260 ml of oxygen (1.26 liters) per minute, which I stated would not be enough. … I tested the device with Mrs. M. and sure enough, it didn’t even come close to meeting her needs.
So, now, what I would like is for Ms. M. to be able to return this device, no questions asked (because I have answered them all here) and with no restocking fee.
But there is something even more important that I think you should consider. …
It is crucial from a safety and ethics perspective that your agents first and foremost know and understand the truth; that the pulsed settings on a POC are just that; settings and NOT lpm.
Second, it is crucial from a safety and ethics perspective that your agents share that truth … with the patient, even if it means acknowledging that the device will likely be insufficient in meeting their needs and therefore, not shipping (selling) the device. …
Also, please keep in mind that when patients are living with a chronic illness, especially one that makes it difficult to breathe, they are willing to try almost anything to reclaim their independence and their lives. This makes them particularly susceptible to high, and sometimes even not-so-high-pressure salesmanship. That’s the ethics portion of the equation.
I understand that sometimes (even though they should), patients are not always properly field-tested or educated on exactly how much oxygen they need under which situations or what device will meet those needs. But if a clinician is telling you that it won’t, please go ahead and believe them and do the right thing by the patient. …
Please help Mrs. M. smoothly return her [model] without any glitches. …
Thank you in advance for your cooperation.
Dr. Noah Greenspan, DPT, CCS, EMT-B, is a board-certified Clinical Specialist in Cardiovascular and Pulmonary Physical Therapy, with more than 25 years of cardiopulmonary physical therapy and rehabilitation experience. His book “Ultimate Pulmonary Wellness” — a continuing source of pride — was published in 2017, and he has made it available for all to read online free-of-charge using that link or by going to the center’s website, www.PulmonaryWellness.com. His “Ultimate Pulmonary Wellness” Lecture & Webinar Series is also open to attend free-of-charge on the website.
Dr. Greenspan founded the Pulmonary Wellness & Rehabilitation Center, a Manhattan-based physical therapy practice specializing in the care of patients with cardiovascular and pulmonary diseases, in 1998. Under his direction, the Center has conducted over 100,000 exercise sessions and has been named “Best of the United States” in the area of cardiovascular and pulmonary physical therapy.
The Alberta Boehringer Ingelheim Collaboration (ABIC) was recently announced at the 2019 BIO International Convention, held in Philadelphia.
The partners hope to address treatment gaps in COPD and its associated other diseases, including diabetes, obesity, and heart failure.
“We are pleased to announce our collaboration with the Government of Alberta and the University Hospital Foundation to advance innovation in healthcare,” Uli Brödl, vice president, medical and regulatory affairs, Boehringer Ingelheim (Canada), said in a press release.
“Patients are at the heart of everything we do, and we are dedicated to developing novel solutions that drive transformative change for a better patient experience,” Brödl added.
ABIC brings together the industry, public, and philanthropic sectors around common goals. The partnership expects to boost the development of new alternatives for patients, by encouraging innovation and applied research in Alberta’s life science sector. The overall aim is to advance health projects and improve the lives of Canadians with COPD and other respiratory diseases.
It is estimated that more than half the people with COPD in Alberta receive a late diagnosis. There are not enough disease and self-management programs, and many times, patients are unaware of the existing ones, the partners said. Additionally, patients do not always reach the relevant services, they said.
To improve this scenario, ABIC will fund projects led by Alberta-based researchers or healthcare professionals. These projects should aim at filling one of three healthcare gaps: early diagnosis and coordinated screening; patient awareness and education related to COPD; and connecting people with the disease to available services.
The selected projects will be supported during their development by Boehringer Ingelheim and the University Hospital Foundation.
“Through public-private-philanthropic partnerships like this, we are able to pioneer innovative solutions that will reduce costs, support a sustainable healthcare system, and improve access to care for patients,” said Christy Holtby, vice president, strategic partnerships, with the University Hospital Foundation.
“We are so grateful for the support from community members through our Foundation to help fund this forward-thinking collaboration,” Holtby added.
Inhaled steroids can be prescribed to treat COPD, particularly in more severe cases in which first-line treatments like beta agonists aren’t enough. Beta agonists work by relaxing muscles in the lungs to widen the airways. Meanwhile, steroids work by decreasing the number of a type of inflammatory cell, called eosinophil, in the lungs.
The relationship between the use of steroids and the risk of lung cancer development — a major cause of death among people with COPD — has not, until now, been assessed.
To learn more, a team led by researchers at the University of British Columbia, in Canada, analyzed data from 1997 through 2007 for 39,676 people in British Columbia with COPD. All patients were over 50 years old (mean age of 70.7 years), and all had received at least three COPD-related prescriptions.
Of the 39,676 COPD patients analyzed, 994 (2.5%) developed lung cancer.
Using this information, along with the prescription data, researchers determined that patients who used inhaled steroids to manage their COPD were much less likely to develop lung cancer — an association that remained constant even when different statistical methods were used.
“Results showed that if you had COPD and consistently used a steroid inhaler, your chances of getting lung cancer were between 25 percent and 30 percent lower, compared to people who took other treatments,” Larry Lynd, PhD, a professor at the University of British Columbia and co-author of the study, said in a press release.
The study, however, has some limitations, the researchers pointed out.
For one thing, it is only showing an association, and not a direct cause-and-effect relationship in which the use of steroids would “prevent” the development of cancer. Additionally, the analysis relied on administrative data and prescription records. While allowing for a larger sample size, this type of data is, predictably, imperfect.
“More work is clearly needed to understand the exact nature of the relationship between lung cancer risks and steroid use,” Lynd said, adding that the team plans to further study the interplay between steroids and lung cancer, as well as to determine which patients might particularly benefit from such treatment.
“Over the next few months, we will find out which COPD patients would benefit the most from inhaled steroids,” Lynd concluded.