Call for a New Dyspnea Assessment Instrument
By Gerene Bauldoff, PhD, RN, MAACVPR
An intriguing editorial was published in the August 2018 CHEST
journal by Dr. Donald Mahler and Dr. Sanjay Sethi that provides a call for the development of a new instrument to measure dyspnea in patients with COPD. While the Global Obstructive Lung Disease (GOLD) guidelines include a treatment paradigm based on dyspnea as measured using the modified Medical Research Council (mMRC), the authors note that in 2016, the Food and Drug Administration (FDA) published a guideline document recommending that COPD drug testing include a measurement of symptom relief, focusing on daily impact of dyspnea.
The conflict arises in that while the FDA supports the need for dyspnea measurement in COPD drug testing, they also report that the commonly used instruments — like mMRC, Borg CR-10, and the Baseline and Transition Dyspnea Scales (BDI/TDI) — have limitations that make their use unreliable as the sole or primary evidence of drug efficacy. This leads to the call for the development of new instruments to measure dyspnea.
The authors note that new COPD treatments need to be developed that are based on the neurobiology of dyspnea. Such treatments can focus on afferent receptors within the respiratory system that send information to the brain. These can take the form of a monoclonal antibody to IL-8, whose mechanism is believed to reduce neutrophil infiltration and thereby alter vagal-mediated airway receptors and nerve fibers transmitting to the brain. Another example is in-phase chest wall vibration postulated to reduce dyspnea by stimulating afferent receptors in the intercostal muscles.
In contrast, medications that impact the central nervous system can also alter dyspnea perception, such as systemic opioids used in an “off label” manner. At this time, the pharma industry is not publicly pursuing new drugs along this line, in part because the FDA has voiced concerns regarding a drug that might relieve dyspnea without otherwise improving or benefiting the underlying pathology in lung disease.
In light of this conflict, the authors recommend the development of a new instrument to measure dyspnea. Such an instrument would be a patient-reported outcome tool. Recent large studies have used standardized electronic daily diary tools. The 14-item EXACT-PRO tool was developed in measurement of exacerbations in COPD. The 11-item E-RS, COPD tool was used to evaluate respiratory symptoms in COPD. While both of these tools are promising, development and ongoing testing of a new instrument is indicated. In conclusion, the authors put forth a call for an exploratory meeting regarding tool development and readers are invited to contact Dr. Mahler and Dr. Sethi if interested. What does this mean for the PR Professional?
This editorial introduces to us the early call for development of a patient-centered dyspnea instrument. Additionally, as PR is a critical therapy for the COPD patient and we have made patient-center outcomes as central to determining the efficacy of PR, AACVPR needs to be represented in the development of new tools by a member volunteer in the exploratory group. Reference:
Mahler DA, Sethi S. (2018). To improve COPD care: A new instrument is needed to assess dyspnea. CHEST 154:
235-236. DOI: https://doi.org/10.1016/j.chest.2018.02.020
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