In this podcast, Susan Jacobs, RN, MS, talks about the new American Thoracic Society's Guidelines on Home Oxygen Therapy, what they mean for clinicians and patients with COPD and ILD, as well as the highly anticipated results of ongoing research.
Additional Resource:
- Jacobs SS, Krishnan JA, Lederer DJ, et al; American Thoracic Society Assembly on Nursing. Home oxygen therapy for adults with chronic lung disease. an official American Thoracic Society clinical practice guideline. Am J Respir Crit. 2020;202(10):121-141. doi:10.1164/rccm.202009-3608ST
Susan S. Jacobs RN, MS, is a research nurse manager in the Department of Pulmonary, Allergy, and Critical Care Medicine and is a nurse coordinator in the Interstitial Lung Disease Clinic at Stanford University in California. She is also the chair of the writing committee for the American Thoracic Society’s Guidelines on Home Oxygen Therapy.
TRANSCRIPT:
Amanda Balbi: Hello everyone, and welcome to another installment of Podcasts360—your go-to resource for medical news and clinical updates. I’m your moderator, Amanda Balbi with Consultant360 Specialty Network.
The American Thoracic Society has just released new guidelines on home oxygen therapy for patients with chronic obstructive pulmonary disease (or COPD) and interstitial lung diseases (ILD). Today I’ll be speaking to the chair of the guideline writing committee, Susan Jacobs, who is a research nurse manager in the Department of Pulmonary, Allergy, and Critical Care Medicine and is a nurse coordinator in the Interstitial Lung Disease Clinic at Stanford University in California.
Thank you for joining me today, Susan. To start, can you give us an overview of the new guidelines?
Susan Jacobs: Yes, I think it's important to start with some background about how they came about. There were 2 publications that came out of ATS in early 2018. One was out of the nursing assembly that surveyed about 2000 oxygen users in the United States and found a description of multiple barriers that patients experienced using oxygen.
The second publication, which grew out of that, was a full-day oxygen workshop report that really went on to document the multiple gaps in evidence that support the rationale for why we prescribe oxygen. It also identified multiple gaps in education and training for patients. This was a multidisciplinary group that included all stakeholders. It really was a broad review of assessing how to optimize care for those patients that use home oxygen. It became clear that there was a need for a review of the evidence. Oxygen is a very common therapy for patients, and it crosses multiple cardiac-pulmonary diseases. But it's quite a burdensome and equipment-laden therapy.
If we're going to prescribe it, it became very clear that we needed evidence review so that we can tell our patients, and have clinicians understand, what to expect in terms of improving either symptoms, quality or quantity of our patients’ lives. This was the rationale and the underpinning for the development of these guidelines.
We went on to convene a diverse guideline panel, including international members and many experts such as physicians, nurses, respiratory therapists, physiotherapists, a patient—oxygen users provide very important input—and, of course, a medical librarian and methodologist. Our panel also included members that had expertise with chronic obstructive pulmonary disease and interstitial lung disease. Some are experts in pulmonary rehab, hospice, respiratory therapy, and oxygen equipment. Many had experience doing guidelines and others, like myself, did not. I had 3 expert co-chairs: Jerry A. Krishnan, Anne E. Holland, and David J. Lederer who each had great experience to guide the group.
Our panel focused on patients who have COPD and ILD, which are the most common groups of patients that are prescribed oxygen. We selected 6 questions using a Delphi process and evaluated and summarized the quality of evidence using the GRADE methodology. From that, we created recommendations. For each of these questions, we did preselect what we considered was our critical outcome for that question - such as mortality or health-related quality of life or physical activity.
Of our 6 questions—and I would say that there were many questions we wanted to ask, but because of the depth and the breadth of the systematic review we did focus on 6 questions.
We had 2 questions that asked if oxygen should be prescribed in patients with COPD and ILD who had severe resting hypoxemia, which we defined as the saturation equal to or less than 88%. For this group, we found the highest quality of data to support the use of oxygen to decrease mortality, which was our critical outcome, in patients who had COPD with severe chronic resting hypoxemia. We had a strong recommendation for that based on moderate-quality evidence. That was really based on the 2 studies that came out in early 1980s that looked at the use of long-term oxygen in patients with COPD with severe hypoxemia.
When we looked at our patients with interstitial lung disease, it was more challenging. Mortality was also our critical outcome. But for the evidence, looking at patients with ILD who had severe chronic resting hypoxemia, we did not find studies that met our inclusion criteria. So, we had to use the in-direct evidence from the other trials that documented a benefit in mortality for COPD and apply that to our ILD population. Again, we made a strong recommendation for, but with very low-quality evidence.
We also asked the question, “Should oxygen be prescribed for patients with COPD who have moderate chronic resting hypoxemia?” which we defined as a saturation between 89% and 93%. For this question, we did not have evidence that supported an improvement in our critical outcome of mortality. So, for this we made a conditional recommendation against prescribing oxygen to those patients who have COPD and moderate resting hypoxemia. This was based on low-quality evidence from just one trial, the LOTT trial [Long-Term Oxygen Therapy Trial].
Then we went on to an area with our next 2 questions, which really looked at patients that had severe exertional hypoxemia. This is something that, in clinical practice, we come across very frequently. We have patients who may be OK at rest but who desaturate when they move around.
We also know that patients are different across disease states. ILD patients have a very rapid, steep desaturation curve compared with similar COPD patients. So, we thought this was an important area of research to review.
It was very interesting to find on our panel, because we had international colleagues, that clinical practice varies dramatically. Some regions don't offer ambulatory oxygen at all, and others offer it only after a blinded trial during which the patient must document improvements in either dypsnea or exercise capacity using a blinded trial of air vs oxygen.
This is important. We know that exertional hypoxemia is a marker of worse outcomes in both populations. But when we reviewed the data and the evidence for our critical outcome, which was health-related quality of life related to mobility and physical activity, we found that the evidence and the studies were difficult to compare because of a variety of eligibility criteria. Some did exercise testing in more of a lab setting, like a 6-minute walk as opposed to daily life. Some included blinding—some did not—of the intervention group, and multiple different instruments were used to measure health-related quality of life.
We did find the results favored an improvement in our outcome of health-related quality of life and exercise capacity and breathlessness in specific settings. Based on the quality of evidence, we made a conditional recommendation for the use of oxygen for severe exertional hypoxemia with moderate-quality evidence for COPD and also a conditional recommendation, but with lower-quality evidence, in patients with ILD.
So, this is clearly—I would emphasize this—an area that we need more research, because this in the clinical setting is a challenge for patients and for clinicians as well, trying to prescribe adequate and maneuverable equipment for our patients who are mobile.
That brings us to our last question, our sixth question. The entire panel unanimously agreed that there was a significant unmet need for access to high-flow, lightweight oxygen portable devices. There is a population of patients who have very high oxygen needs. We defined high flow as above 3 L continuous flow. These are patients that need high flow and that are also very active and mobile outside of their home.
The question we asked was, “Should patients who have chronic lung disease who are mobile outside the home and require high oxygen flow rate during exertion, should they be prescribed liquid oxygen?”
As you know, there are different modes of oxygen. There’s compressed gas. There's liquid, and there's concentrators. For portability, the only lightweight option that can provide continuous high flow above 3 L is a liquid canister.
Based on our review, we did not find any studies that did any type of comparative investigation comparing liquid portable devices with others. So, there was minimal evidence, but in view of what we were able to see in some data, there was some health-related quality of life benefits and improved mobility. But again, there were no studies that directly compared liquid oxygen to other devices.
Based on the evidence we did make a conditional recommendation to prescribe liquid oxygen for that subset of patients based on very-low-quality evidence.
That's an overview of our 6 questions.
Amanda Balbi: So these are the first oxygen guidelines specifically for adults to be developed in the United States. Can you tell us more about that?
Susan Jacobs: This is the first oxygen guideline to be developed in the United States; we don't have a previous version. There are other guidelines that have been developed in the past, including some disease-specific guidelines, like the idiopathic pulmonary fibrosis guidelines or the COPD GOLD statement. They've touched on some recommendations of oxygen use in that population.
There were other societies such as the British Thoracic Society and the Australia-UK guidelines that were published previously, I think in 2015 and 2016. They were also very complete guidelines, but ours is a bit more updated and include the LOTT study, for example.
Ours is an extensive, detailed, peer-reviewed guideline that provides a new guidance for oxygen therapy in patients with moderate hypoxemia, and it really updates the guidance on prescribing ambulatory oxygen for both COPD and ILD patients.
I think what may also make ours different is that we did include a best practice statement recommending patient educational support and training, which can be critical for adherence to therapy and treatment outcomes.
Ours was a very diverse and expert panel. To re-emphasize, we took this task very seriously. In addition to combing through the evidence for the 6 questions that we unanimously agreed upon, there was also a minimal standard of care emphasized. That is not always something that can be met and I think this guideline will provide that blueprint for clinicians for what that standard is. There are resources to help clinicians and patients get that education and training. So, we would consider that best practice statement equal in importance with our 6 guideline questions.
Amanda Balbi: What has the research shown recently about home oxygen therapy?
Susan Jacobs: There may be research I'm not aware of, but we haven't had a lot of publications about the use of home oxygen specifically. However, there is research that is ongoing. I would say that the area that we're seeing a great interest is in technology research on developing improved devices- portable oxygen concentrators for example.
There's research looking at improving the trigger mechanism in POCs. These are on a pulse mechanism which doesn't always trigger, especially in our interstitial lung disease patients who can have a very rapid shallow breathing pattern. There is technology research on portable concentrators, noninvasive ventilation, and portable devices to improve oxygenation and mobility. There are some feedback autotitration devices where, instead of the patient having to take a tank out of a backpack or walk up their stairs to change flow rates, they could have either a remote control, or they could have a device that is continually reading their saturations and has a feedback mechanism to automatically increase their flow rates to meet their changing demands.
Dr. Anne Holland also has a study underway comparing the use of POCs in improving physical activity. She's going to do a randomized trial to look at a POC vs a POC with air. It will be a blinded trial, and that's important. We need the data to document the benefit for patients that are mobile.
There's also an interest in cost analysis. Of course, we want to drive policy to improve oxygen delivery to patients and the reimbursement to our durable medical equipment companies. As a whole service area, it’s important to deliver adequate devices to our patients. So that's another area of research; I guess you could combine it with service quality and cost benefit.
There are different areas of research that are extremely needed, and we look forward to this for our patients in particular. We want oxygen to improve, not be an obstacle, to our patients’ mobility inside and outside of the home.
Amanda Balbi: What are the overall clinical take-home messages that you'd like to leave our audience with today?
Susan Jacobs: That's challenging, but I would say the first that I alluded to would be the best practice statement. This guideline includes a best practice statement that the panel critically addressed. We consider it a minimal standard of care for every clinician to provide safety information, education, and training to their patients on oxygen, as well as ongoing monitoring.
We included in our recommendations to retest patients on a regular basis, including after discharge from a hospital stay. We certainly would want to retest a patient to find out if they could come off oxygen, just as importantly as if they need to increase their oxygen prescription. That should be a standard of care for every patient using home oxygen.
I think part of that education is because of some of our conditional recommendations. This is an area that needs what we would call “shared decision-making.” That would be a discussion between the prescribing clinician and the patient to discuss jointly when to start and stop oxygen therapy based on our evidence that we have for both resting and exertional home oxygen use. So, a big emphasis for a minimal standard of education for these patients, and an interchange between the clinician and the patient.
I think the second point that we really struggle with that I would say is a priority, is that these guidelines identified a need to really have more research to look at liquid oxygen as an option, or other novel portable oxygen devices. We need to improve portable devices to last longer and to have a higher capacity of flow so that our patients can be out of the home.
The last message is that the evidence gaps for patients with exertional hypoxemia, and the use of oxygen in patients with ILD, are really highlighted in this guideline, and we certainly hope this spurs investigators to address these. Filling these research gaps will drive policy improvements and help our patients.
Amanda Balbi: Thank you so much for speaking with me today and answering all my questions.
Susan Jacobs: You're very welcome. We hope that this publication improves the care of our home oxygen patients and drives some great device research, as well as gets that essential data to support our patients’ oxygen prescriptions. We also want to thank the ATS for their support of this important project.
