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Summer 2019

FreshAireTM VitalAire's publication for Healthcare Professionals to help you stay up-to-date on a variety of respiratory related topics.

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Does the future of chronic disease management rely on connected devices? 1

In our houses, at work, while commuting…. We’re surrounded by tiny, intelligent devices more and more everyday that capture data about how we live, what we do and where we do it. These devices are connected and share our information in order to anticipate or respond to our needs, to solve our problems and eventually, in the great scheme of things, to save our lives. Indeed, smart devices and technology have been introduced to help tackle some of the most significant challenges health care systems are facing today: reducing the costs and resources utilization and improving patient treatment outcomes. One way to succeed might be to shift patient care from hospital to home. While the availability of oral and subcutaneous medications makes home-administration a reality for many diseases, treatment adherence in a decentralized, uncontrolled setting can be negatively affected by infrequent direct interactions between patients and health care professionals. To ensure the adherence of the patient and to enable an ongoing dialogue with the HCP, a multitude of connected devices with applications have been developed to facilitate the management of chronic conditions such as diabetes, multiple sclerosis, schizophrenia, bipolar and depressive disorders, asthma and COPD.

Random Controlled Studies and prospective studies in asthma patients have been conducted with the SmartInhaler™ which is a platform that includes adherence trackers for patients and HCPs, dosing reminders, and allows insights into medication usage. SmartInhaler™ medication sensors wrap around a patient’s existing dry powder or metered-dose inhaler and automatically send usage data to their smartphone using Bluetooth®. The corresponding app analyzes, stores and monitors inhaler use. SmartInhalers™ were subject to a National Institute of Health & Clinical Excellence (NICE) Health Technology Assessment. While an improved adherence with the SmartInhaler™ technology was found across studies, NICE noted that these available studies were not adequately designed to show whether improved adherence is associated with significantly improved outcomes.

Random Controlled Studies and prospective studies in asthma and COPD patients have been conducted with the Propeller system which includes an electronic inhaler sensor that attaches to an existing third-party inhaler. The sensor monitors the date, time and frequency of medication use and transmits these data back to secure servers through a smartphone app or hub-base station. Location data are collected on medication use among patients who have a smartphone. The sensors regularly transmit data back to the server or sync through the smartphone or hub. The Propeller is comparable to the SmartInhaler™ technology. The conducted studies showed a decrease of use of Short Acting Beta Agonist, a decrease in the rate of rescue medication and an increase in symptom-free days.

These studies show that there is definite initial evidence that these tools could be a cost-effective tool to improve treatment adherence, and ultimately outcomes, outside of a controlled setting for chronic respiratory conditions. Digital homecare is expected to decrease uncertainty around patient adherence, while maintaining patient-centric disease management.

Through real-time collection of patient health data, intelligent devices can help detect adverse events or complications before they occur, allowing physicians to differentiate between pharmacological resistance and improper medication use. This may prevent severe treatment-related events or treatment failure that would otherwise consume costs and resources (including hospitalization). With connected devices, real-time decision-making concerning continuation of treatment (including whether to maintain or alter the dose) or treatment discontinuation might become easier.

To ensure broad acceptance of connected devices, some barriers have to be overcome such as; data privacy, connectivity issues, lack of customization of the applications, lack of motivation of patients, reimbursement models and HCP role and remuneration...

If these challenges can be addressed in a way that is agreeable to all stakeholders, it is not too presumptuous to say that the connected devices should facilitate and improve patient involvement in disease management in a flexible care setting, enable early treatment decisions, and finally complement value-based reimbursement models. Of course, further studies will have to be conducted to confirm their impact on these later outcomes. 1
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Adherence to sleep apnea treatment affects risk of hospital readmission

A retrospective cohort study at the Long Beach Veterans Affairs hospital in California on patients with OSA and were hospitalized between 2007 January the 1st and 2015 December the 31st has demonstrated a direct correlation between CPAP non-adherence and 30-day readmission rates. Non-adherent patients were three times more likely to be readmitted to the hospital within 30 days for all cause of hospital readmission. The leading cardiovascular causes for readmission in these non-adherent patients were: atrial fibrillation, myocardial ischemia and congestive heart failure, all of which are linked to untreated sleep apnea.

Until this study was conducted, the role of CPAP non-adherence in 30-day readmissions was never really explored. This study carries important implications, as it suggests that CPAP therapy may be an important modifiable target for reducing hospital readmissions.

Out of 2,077 records reviewed, 345 patients were included in the study. To be included in the study, patients had to be diagnosed with OSA (confirmed on polysomnography data on chart review.) and to have CPAP adherence data within 12 months preceding their hospital admission. If there was no CPAP adherence data within the 12 months preceding the hospital admission, the patients were excluded. CPAP adherence is defined as CPAP use for 4 or more hours per night on 70% of nights during a consecutive minimum of 30-day period based on Medicare definition. Out of these 345 patients, 183 were adherent and 162 were non adherent. The adherent group had a total of 215 initial admissions, and the nonadherent group had a total of 268 initial admissions. Patient characteristics were obtained from the electronic inpatient and outpatient data recorded at the hospital. Baseline characteristics included: age on admission, sex, body mass index (BMI), living situation (alone or with others), race, baseline apnea-hypopnea index (AHI), residual AHI, comorbidities at the time of initial admission, and adherence to prescribed medications.

Patients with OSA who were non-adherent had higher 30-day all-cause and cardiovascular-cause readmissions. The cardiovascular-cause readmissions in the nonadherent group were mostly due to atrial fibrillation (29.0%), myocardial ischemia (22.5%) and congestive heart failure (19.3%). These findings are aligned with the facts that atrial fibrillation is known to occur more frequently with increased number of apneic episodes and severity of hypoxemia, and CPAP therapy is associated with improved left ventricular systolic function and decreased atrial fibrillation occurrence. Effective use of CPAP has also been associated with decreased sympathetic activity, improved blood pressure and overall decreased cardiovascular events. Pulmonary-related readmissions were higher in the CPAP nonadherent group, however it did not reach the level of significance. Finally the most common non cardiac and non pulmonary causes of all-cause readmissions in the nonadherent group were urologic (10.7%), infection (8.0%) and psychiatric (5.3%). Although the reasons for these readmissions seem broad and unrelated, there is a growing body of evidence that supports increased urinary tract symptoms, immune dysfunction and psychiatric disorders in OSA.

This study has several limitations that merit discussion: it was performed in a single Veterans Affairs Medical Center, limiting generalizability. However, despite this limitation, the readmission rates in CPAP-adherent population and the Medicare and general VA population are relatively similar. Also as with all retrospective studies, the design limits the ability to prove a causal relationship and there is potential for bias results.

Nearly 30 million adults in the U.S. have obstructive sleep apnea. The high prevalence of OSA, its correlation to multiorgan health and increased healthcare utilization makes it an important clinical and public health disease to target. The gold standard to treating OSA is the use of CPAP machine. Encouraging CPAP adherence with incentives may become a lever for action to reduce hospital resources utilization and readmission rates. 2

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Ask an expert: Long term PAP adherence

Interview with Jane Baddeley

We wanted to hear the perspective of Jane Baddeley, previous co-owner and current managing director of Sleep Disorders Clinics in Southern Ontario, on long term adherence and why is it so special.

Can you describe your background and role? I trained in South Africa as a Registered Nurse and then specialized in mental health nursing after graduating from Mount Royal University in Calgary. After completing a Master of Arts in Organizational Analysis and Behavior, I worked for a consulting firm in Toronto mostly involved in change management projects. I became involved about 20 years ago with the Sleep Disorders Clinics as co-owner and director of the three laboratories in Southern Ontario. I hold the Certificate in Clinical Sleep Health (CCSH) from the BRPT.

Can you define long term PAP adherence in few words/numbers and tell why is it so important?Most of the time, sleep apnea is a lifelong partner and therefore treatment should be anticipated as being for life. This can be overwhelming for patients at the beginning of the therapy. The current definition of PAP adherence is an arbitrary one which is based on funding criteria in the USA. It would definitely be more accurate to get away from the well-accepted statement “4 hours, 5 or more nights per week” and refer to adherence as being when a patient uses CPAP for the whole duration of sleep, has a resolution of symptoms of sleep apnea and an AHI below 5.

Long term adherers are often happy on CPAP and they often talk about their CPAP using the personal pronoun “my” CPAP. Long term adherence relies largely on two components: self-efficacy of the patient (“I know I can do this and it will be good for me”) and an ongoing relationship with a trained healthcare professional. S​urprisingly, long term adherers do not tend to have worse symptoms or more severe OSA, they are the people who trust that the diagnosis is accurate and that they are supported in their treatment. There is a real difference between the adherers and non-adherers who sort of dabble with treatment. We also see a subset of patients who are using CPAP almost four hours and close to 5 nights per week after 6 months or more on CPAP. These patients may be struggling with their therapy but they are persevering for some reason – a phone call or a bit of follow up might turn them into long term adherers.

What makes an adherent patient so special? Maybe what makes them special for us is that we are delighted when we see them! They are the ones we like to keep in the waiting room, as they rave about how happy they are on CPAP. But more importantly, especially for the severe OSA patients, we know that the ones who are adherent are breathing normally at night with resolution of symptoms, resolution of apnea and decrease in risks of comorbidities such as heart disease or diabetes. Our job is to keep them adherent for life.

It is also necessary to remember that an HSAT is only testing OSA and not other sleep disorders such as insomnia, parasomnias, movement disturbances in sleep or Restless Legs Syndrome.

Is it possible to determine if a patient who has been sent for testing will be adherent at the early stages of the therapy or even before? If yes, how? For some people it is as simple as asking. We notice that patients who know about CPAP, have friends, coworkers or family on CPAP, are often more enthusiastic about CPAP or at least more willing to try. Patients who suspect that they have sleep apnea are also more open to treatment. I often ask a patient if they suspect that they have apnea before I tell them that they do, so that I can gage how receptive they are. I suppose this is a way of assessing self-efficacy; they believe they have something that needs treating, trust our diagnosis and then are willing to use the therapy we recommend.

The patients who are skeptical off the bat are very hard to convince. They may think that all we do is prescribe CPAP and force it on everyone. This is why it is crucial to educate our patients on the impact of OSA on their health and wellbeing, as well as provide them with an accurate diagnostic test result with a reliable physician interpretation. Another notable fact that we see is if a patient is non-compliant in the first 30 days they are unlikely to be compliant subsequently, so those first 30 days are crucial, with early intervention in the first week if the patient has difficulty. With online monitoring it has made our jobs a lot easier and we are able to step in quickly if we see trouble even after the first couple of nights.

Is it possible to determine if a patient who has been sent for sleep testing, does not have sleep apnea even before the test? If yes, how? The use of good screening tools (​STOP BANG, ESS, BERLIN, OSA 50​, adjusted neck circumference) can help identify the likelihood of the patients having apnea. However, ruling out OSA with only screening tools or home sleep apnea testing (HSAT) can be problematic, as not all OSA patients are sleepy, not all of them snore. This is why the American Academy of Sleep Medicine recommends to follow up any negative level 3 (HSAT) testing with a level 1 sleep study if the patient is symptomatic.

It is also necessary to remember that an HSAT is only testing OSA and not other sleep disorders such as insomnia, parasomnias, movement disturbances in sleep or Restless Legs Syndrome.

Why is it so important for a referral physician to screen their patient before prescribing a sleep test? If screening was performed by GP or referring physicians, then it would definitely decrease the number of tests done on patients without OSA. There are some good validated screening tools such as the ​STOP BANG, ESS, BERLIN, or OSA 50,​ that can help GPs to identify the suitability of the patient for OSA testing. It is also necessary to remember that a L3 test is NOT a screening tool but a diagnostic tool, so doing it on patients who probably don’t have OSA is not valuable for anybody (the sleep clinic, the patient, or the referring doctor).

IWhat is the impact of mis-diagnosing OSA? Diagnosing OSA in a patient who doesn’t have it is one thing, but missing the diagnosis of OSA in a patient who does is more problematic. Home tests tend to underestimate the level of apnea as they cannot identify if a patient is sleeping or not. If the patient is awake for half the night and asleep with an AHI of 50 for the other half, the AHI is “diluted” by 50%. This becomes even more problematic with patients who have moderate OSA (AHIs between 15 and 30), as the results of the home test can be deemed as falsely negative.

The HCP should always question the results of a sleep test if they are not aligned with his/her own expectation regarding the patient. This expectation should be based on screening tools, assessment of symptoms, BMI, and a quick assessment of the airway (Malampatti score and tonsils). If the sleep lab or clinic has used automated scoring and the results do not fit with your assessment of the patient, the HCP should take a look at the raw data to check its accuracy (for HCP with sleep experience) and pay careful attention to the doctor’s interpretation. As for any tests, it is important to question the results if they seem inaccurate which is particularly true for home sleep testing. The home sleep testing should ideally be followed by a morning questionnaire, filled in by patient and bed partner, if applicable, to assess the quality of sleep during the night.

The risk of mis-diagnosing or missing the apnea is that you may leave a patient untreated with all the potential health and quality of life consequences.

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Product Update: SimplyGo Mini

Powerful, elegant, durable and lightweight the SimplyGo Mini Portable Oxygen Concentrator sets a new standard for oxygen therapy on the go. As the smallest and lightest Portable Oxygen Concentrator ever developed by Philips Respironics, SimplyGo Mini is built for today’s patients with an attractive and sleek design, an easy-to-remove external battery, an easy-to-read screen and a strong, comfortable carrying case. This new POC is light (5 lbs) and definitely intuitive for the patient to use. It is also compliant with all FAA requirements.

SimplyGo Mini is part of the Right Fit, a complete portfolio of oxygen products and programs developed by Respironics and inspired by patients and built for business. It is designed and rigorously tested to be reliable and durable in real-world environments, undergoing the same testing regimen as its counterpart, the proven SimplyGo POC.

Because patients are looking for more independence and freedom, SimplyGo Mini allows them to be out with their oxygen up to 4.5 hours with a single battery and up to 9 hours with double batteries (at a pulse setting of 2). The SimplyGo Mini can provide pulse dose therapy up to a setting of 5.

If you know of a patient who may benefit from this model of POC, contact VitalAire.
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Toward Better Management for Asthma: From Smart Inhalers to Injections to Wearables, Researchers Are Finding New Ways to Improve Asthma Treatment.

Yan W. IEEE Pulse. 2018 Jan-Feb;9(1):28-33. doi: 10.1109/MPUL.2017.2772398. PMID: 29373855

Smart inhalers: will they help to improve asthma care?

The Pharmaceutical Journal, April 2017, Vol 298, No 7900, online | DOI: 10.1211/PJ.2017.20202556

The official website of the STOP BANG Questionnaire

Evaluation of Clinical Tools to Screen and Assess for Obstructive Sleep Apnea

Charlene Gamaldo, MD1; Luis Buenaver, PhD1; Oleg Chernyshev, MD, PhD2; Stephen Derose, MD, MSHS3; Reena Mehra, MD, MS4; Kimberly Vana, DNP5; Harneet K. Walia, MD4; Vanessa Gonzalez, MPH6; Indira Gurubhagavatula, MD, MPH7,8
1Johns Hopkins University, Baltimore, Maryland; 2Louisiana State University, Shreveport, Louisiana; 3Kaiser Permanente, Pasadena, California; 4Cleveland Clinic, Cleveland, Ohio; 5Arizona State University, Phoenix, Arizona; 6American Academy of Sleep Medicine, Darien, Illinois; 7University of Pennsylvania, Philadelphia, Pennsylvania; 8Corporal Michael Crescenz VA Medical Center, Philadelphia, Pennsylvania

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