COPD Foundation Comments

PCORI's Draft National Priorities for Research and Research Agenda

Patient-CenteredCOPD Foundation Outcomes Comments: Research Institute (PCORI) National Patient and Stakeholder Dialogue

National Press Club, Washington, DC February 27, 2012

“Keep the Patient Voice Central” COPD – Almost always preventable; Almost always treatable; someday curable.

Mission: The COPD Foundation’s mission is to develop and support programs, which improve the quality of life through research, education, early diagnosis, and enhanced therapy for persons whose lives are impacted by Chronic Obstructive Pulmonary Disease (COPD).

Impact and incidence: COPD, is an umbrella term used to describe progressive lung diseases including emphysema, chronic bronchitis, refractory (non-reversible) asthma, and some forms of bronchiectasis. This disease is characterized by increasing breathlessness. The NIH, National Heart, Lung and Blood Institute estimates that 12 million adults have COPD and another 12 million are undiagnosed. Smoking is not the only cause of COPD; second-hand smoke, occupational dust and chemicals, air pollution and genetic factors such as Alpha-1 Antitrypsin Deficiency also cause COPD. Dr. Susan Shurin, Acting Director, of NHLBI responsible for the Learn More Breathe Better© COPD education and awareness program notes that, “Half of the people living with COPD don’t know it even though it is relatively simple to diagnose with spirometry.”

Cost: COPD is currently the third leading cause of death in the US and rising. COPD while chronic is often characterized by exacerbations that can cause considerable lung deterioration that possibly could be avoided with medication compliance and education. There are 500,000 to 1 million hospitalizations for COPD each year, and because of these high rates of hospitalizations and readmissions the Affordable Care Act targeted COPD as an area of improvement in readmissions. Costs related to COPD are rising and estimated to be about $50 billion per year.

Co-morbidities: A majority of patients with COPD also have at least one other chronic condition and receive care from more than one healthcare provider (primary care physicians, pulmonologists, nurses, or respiratory therapists). In 2006, the COPD Foundation presented the results of its study on co-morbidities at the American Thoracic Society International Conference. The COPD and Co-Morbidities Survey identified other chronic conditions and the extent of these illnesses, and also determine use of medications for these additional illnesses. 81% percent of the household sample with COPD described having over six co-morbid conditions. Co-morbidities: Thus it is critical that not only do individuals with COPD receive proper diagnosis and treatment but that it is also recognized that they will need proper diagnosis and treatment for co-morbid conditions that may also be chronic in nature.

Utilization of Healthcare Services: Individuals diagnosed with COPD and those with COPD who are undiagnosed seek treatment from Emergency Services when they find themselves in an episode of severe respiratory distress. (Survey: “Confronting COPD in America” found that in those age 45-54, 27% had at least one emergency room visit within the past year for their condition.) Common in emergency services is to treat the patient by relieving the present distress and discharging them with the directive to follow up with their personal physician. Relieved that the episode is past, individuals are eager to resume their usual schedule and are often unable to afford an office visit or don’t even have a personal physician. Thus there is no medical follow up, leading them to repeat this scenario, requiring expensive emergency services again, within months, weeks, or even days. Improvement needs to be made in understanding transitions through the healthcare delivery system while continuing to meet the immediate clinical needs of the COPD patient.

COPD Infrastructure is built for Research: The COPD Foundation has worked with the FDA to establish biomarkers that will facilitate expedited drug development. The COPD Foundation has worked with the National Institutes of Health to encourage funding of research that looks at the relationship of COPD and genetics while exceeding its goal of recruiting 10,000 research subjects the largest COPD cohort ever organized. COPDGene has enrolled more than 10,000 smokers with and without COPD across the GOLD stages that includes traditionally underserved populations of both Non-Hispanic whites and African-Americans. The COPD Foundation Research Registry is a confidential database of individuals diagnosed with COPD or at risk of developing COPD. The Registry was established in 2007 by the COPD Foundation to help researchers learn more about COPD and to help people interested in COPD research find opportunities to participate. The Registry operates under the direction of the COPD Foundation’s Board of Directors and is guided by an Oversight Committee comprised of leaders in the medical, ethical, scientific and COPD communities and ensures the strictest confidentiality of participant information.

COPD is a condition with multiple co-morbidities where studies are especially needed to improve care and outcomes. COPD is a condition that has a high probability of improvability via research with the potential for new evidence to improve patient health, well being, and the quality of care.

Recommendations to make the patient voice central:

1. COPD Foundation broadly agrees with the prioritization criteria as long as the patient voice remains central and research remains community based; 2. COPD Foundation believes that patient advocacy groups need to be more closely involved with the selection of specific topics or research grants to ensure that questions are relevant to patients, that outcomes are patient-centered, and that there is a plan to keep patients engaged with the review of progress reports; 3. Because patient advocacy groups have successfully worked with all stakeholders and often define our constituency as patients, healthcare providers, academia, researchers, clinicians, industry and government The COPD Foundation believes that patient involvement is essential in the collaboration, dissemination and implementation activities of the research outcomes; 4. PCORI’s criteria to identify national priorities for research, taking into account factors of disease incidence, prevalence, and burden in the US make COPD, which is an under-recognized and under-studied condition a perfect candidate to receive greater attention;

5. For the sake of the one COPD patient who dies every four minutes please prioritize COPD as an area that will have a high probability of improvability via research.