Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.

for patients receiving pulmonary therapy for COPD, would results be improved by normalizing blood gases and relieving dynamic lung hyperinflation prior to therapy.

Does your question include a comparison of different health care approaches? (If no, your topic will still be considered.)

yes

If yes, explain the specific technologies, devices, drugs, or interventions you would like to see compared:

pulmonary rehabilitation with and without WaveRider therapy before rehabilitation.

What patients or group(s) of patients does your question apply to? (Please include specific details such as age range, gender, coexisting diagnoses, and indications for therapy.)

COPD diagnosis

dyspnea on exertion gender neutral age neutral

Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)

no

Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)

better rehabilitation results reduction in dyspnea on exertion improved elimination of retained secretions fewer and less severe exacerbations

Describe any health-related risks, side effects, or harms that you are concerned about.

occasional sea sickness occasional difficulty with breathing pattern

Appropriateness for EHC Program

Does your question include a health care drug, intervention, device, or technology available (or likely to be available) in the U.S.?

yes

Which priority area(s) and population(s) does this topic apply to? (check all that apply)

EHC Priority Conditions (updated in 2008)

• Pulmonary disease/asthma

AHRQ Priority Populations

• Elderly
• Individuals with special health care needs, including individuals with disabilities or who need chronic care or end-of-life health care

Federal Health Care Program

• Medicaid
• Medicare

Importance

Describe why this topic is important.

COPD is the 3rd leading cause of death in the US. Annual costs to the health care system exceed $20B. Reducing the severity and frequency of exacerbations will improve QOL while saving Medicare/Medicaid significant amounts of money.

What specifically motivated you to ask this question? (For example, you are developing a clinical guideline, working with a policy with large uncertainty about the appropriate approach, costly intervention, new research you have read, items in the media you may have seen, a clinical practice dilemma you know of, etc.)

My mother died of COPD. I probably have it, but resist seeking a diagnosis. My siblings and I have developed a non-invasive therapy and are trying to find a way to get it to the people that need it. The first thing we need to do is determine how to best use it and how well it works.

Does your question represent uncertainty for clinicians and/or policy-makers? (For example, variations in clinical care, controversy in what constitutes appropriate clinical care, or a policy decision.)

yes

If yes, please explain:

All a pulmonologist can offer me is drugs with significant side effects. Therapy for COPD hasn't changed since the disease was recognized. There is no chemotherapy, no radiation, no clot busters, no surgery, nothing but drugs of debatable effectiveness.

Potential Impact

How will an answer to your research question be used or help inform decisions for you or your group?

A clear answer on how well the device works would, if it works, make it easier to gain acceptance. On the other hand, if it doesn't work, we can move on.

Describe the timeframe in which an answer to your question is needed.

We submitted a SBIR grant application to fund this research to the NIH, but it didn't pass muster.

Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.

COPD is a disease of mostly old people, and most of us feel like we brought it on ourselves and somehow deserve it.

Nominator Information

Other Information About You: (optional)

Please choose a description that best describes your role or perspective: (you may select more than one category if appropriate)

A clear answer on how well the device works would, if it works, make it easier to gain acceptance. On the other hand, if it doesn't work, we can move on.

Are you making a suggestion as an individual or on behalf of an organization?

Organization

Please tell us how you heard about the Effective Health Care Program

via Dr. Harver