Article By: Alex Stenzler
Respiratory Therapy Vol. 19 No. 1 Winter 2024
In this feature, Respiratory Therapy interviews clinicians and healthcare providers about the actual application of specific products and therapies. This article is a follow-up interview with Alex Stenzler, the Chief Science Officer of Monitored Therapeutics, a telehealthcare company. He is also the President of 12th Man Technologies and was the former Vice-President of Advanced Technologies for Viasys Healthcare, Cardinal Health and CareFusion 207, Inc.
I’d like to follow up from our last interview and further explore spirometry testing in the primary care physician (PCP) office. Before going into the interview, please remind our readers who Monitored Therapeutics is and what it does.
Monitored Therapeutics (MTI) is a disease management company focused on collecting physiologic data from remote sensors. MTI services three segments of the healthcare market. The primary segment we serve is the disease specific monitoring needs of healthcare institutions. For example, we monitor pre and post lung transplant patients for a number of institutions where we alert caregivers to sudden drops in lung function allowing them to intervene earlier. We also monitor patients with asthma, COPD, interstitial lung disease and cystic fibrosis.
We have a clinical trials group that serves our second segment for the pharmaceutical industry. Our solutions are utilized worldwide in studies remotely monitoring lung function as an endpoint from patients at home, as we manufacture one of the very few diagnostic spirometers that has been tested and certified for home use.
The third segment brings our revolutionary avatar-assisted, lab-quality spirometry GoClinic platform into the primary care physician space, allowing patients with lung disease to be diagnosed earlier and then managed with home monitoring and supported by educational materials right on their smartphones. The GoClinic is the starting point of an effective respiratory continuum of care, allowing clinicians to easily test, evaluate, and effectively manage their patient’s lung health.
In our last interview you discussed diagnostic spirometry measurements in the PCP office as the best location for identifying patients with chronic lung disease. However, there are reported simpler ways to identify patients with COPD using a series of questions and the measurement of just Peak Expiratory Flow. Are you familiar with that approach?
Yes. This is a relatively new alternative screening tool introduced for primary care offices called the COPD Assessment in Primary Care to Identify Undiagnosed Respiratory Disease and Exacerbation Risk or “CAPTURE” that was developed with support from the NIH. This was designed by a national group of researchers to identify adults with COPD symptoms severe enough to treat, but who haven’t received a diagnosis. The study was conducted at seven U.S. clinical research network centers from October 2018 to April 2022; the trial analysis involved adults, ages 45-80. They screened 4,325 people using the CAPTURE algorithm and then had all 4,325 people do formal diagnostic spirometry testing to confirm the presence of COPD or identify normal lung function.
Do you believe this “CAPTURE” program will be effective?
While this might seem like a simple way to screen for COPD, it turned out to not be very effective. Let me share a table that contains the results from that study. With a population size of more than four thousand participants, it was a sizable endeavor. Note that the CAPTURE program missed fifty-seven participants who actually had COPD based on diagnostic spirometry measurements. However, more importantly, it mis-diagnosed 479 participants, indicated as having COPD, while they were actually normal and who, with only CAPTURE screening, would have been referred for a pulmonologist evaluation.
Not only were these normal participants burdened with the thought that they had lung disease while waiting for an appointment with overburdened pulmonary practices, but further overburdened the pulmonologists with unnecessary referrals at a significant cost to them and insurers. Additionally, 47% of the participants who were diagnosed with COPD by the gold standard of spirometry had only mild COPD that probably could have been adequately managed by the PCP with limited guidance. The researchers do admit that the CAPTURE program has a low sensitivity (32.1%) as evidenced by the high false positives.
Therefore, we continue to strongly believe that the triage for patients with respiratory diseases is best and most cost effectively performed in the PCP office using a diagnostic spirometer, assuming that the quality of the data can match the quality of data performed in the pulmonologist’s office or hospital laboratory. I’ve included the references to the CAPTURE publications at the end for your readers.
They used Peak Flow meters in CAPTURE. Do you believe therefore that Peak Expiratory Flow is inadequate as a diagnostic or screening tool?
The CAPTURE researchers specifically explored the diagnostic accuracy of Peak Flow Meters and noted that Peak Flow had a low sensitivity, reinforcing the importance of using diagnostic spirometry and not a Peak Flow Meter in the PCP office. While a Peak Flow Meter may have some uses, diagnostic spirometry is the only test to accurately detect lung disease.
If all the PCP offices you identified in our previous interview begin to perform spirometry testing, the number of bills to payers for testing will increase significantly. Do you believe there will be pushback from the payers that reimburse the physicians for the tests?
I am certain that all payers are concerned with the potential for overuse of any test. Considering that close to 80% of people with COPD are undiagnosed, a program to identify them will certainly increase the number of spirometry tests performed. However, since early diagnosis is expected to reduce the slope of disease progression through earlier disease management, it would be anticipated that the total long-term cost of care for this population overall and therefore payer costs, will be lower.
How can you assist the PCP with identification of the appropriate patients to screen for lung disease so they don’t abuse the system and risk an adverse payer response?
As a starting point, MTI has collaborated with pulmonologists on a suggested list of “Indications for Spirometry” so that the PCP office would consider these when deciding to perform tests. These include individuals who are:
- Older than 40 years of age with a history of smoking.
- Or Have dyspnea and/or chronic cough or sputum production.
- Or have a history of recurrent lower respiratory tract infections.
- Or have a history of exposure to risk factors such as chemical or particulate exposure.
- Or have a history of wheezing, shortness of breath, chest tightness, and cough that vary in intensity over time.
These are clear indications. Once a PCP has decided to perform spirometry testing, MTI has the patient fill out a more detailed respiratory history questionnaire. The respiratory history questionnaire collects relevant exposure information, exacerbation history, symptoms, and potential interventions currently being used to treat their symptoms. This information is then included in the report generated by the platform and made available to insurers if requested.
Obviously, if the spirometry detects lung disease, then the test was justified. However, if the test results are normal, and there was no history to suggest a need for the test, that will also be obvious.
What do you think will be the impact on chronic disease management by screening at PCP offices?
The first principle regarding the importance of screening is that if you don’t know the disease is there, you can’t manage it. I firmly believe that if we can identify lung disease early, and most importantly, where the patients are most likely to be seen, we can have a significant impact. Getting gold standard spirometry in the PCP office is the key to effecting this impact.
How will MTI’s remote monitoring programs interplay with the respiratory disease evaluation screening at the PCP office?
MTI’s semi-automated workflow platform for the PCP guides the staff through all of the steps for patient respiratory history, disease severity questionnaires, as well as pulse oximetry and pre and post bronchodilator spirometry. It then generates a report for the PCP that includes all the collected information and provides an ATS/ERS clinical impression. Depending on the patient’s specific disease and severity, the PCP has the option of referring the patient for a range of remote support elements including education, medication monitoring or physiologic monitoring. If patient specific threshold criteria are met as identified by the ATS, it will advise the PCP to consider referring the patient for a pulmonologist evaluation. This approach integrates the PCP screening program directly with the MTI remote monitoring programs.
It seems like a more holistic approach to chronic disease. Is that a reasonable interpretation of your goals?
Most respiratory diseases, unlike many other diseases, cannot be cured, and the best outcome is to alter the slope of decline with early identification that is supported with proper medication adherence, education, remote monitoring and behavior modification. We believe that if we don’t provide all of these management aspects, it will not return the long-term outcomes we seek. On the other side, if we can successfully deliver all of these components in a disease management platform, we can have significant impact for these patients, lower overall healthcare costs, and improve the quality of life for them.
Will you be willing to come back in a year to give us an update on how the program progresses?
I would very much like to speak with you again in a year and inform your readers as to our progress in changing the lives of people with chronic diseases.
1) Fernando J. Martinez, MD, MS, et al., Discriminative Accuracy of the CAPTURE Tool for Identifying Chronic Obstructive Pulmonary Disease in US Primary Care Settings. JAMA. 2023;329(6):490-501
2) Fernando J. Martinez, MD, MS, et al., A New Approach for Identifying Patients with Undiagnosed Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2017 Mar 15;195(6):748-756.