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NHLBI Federal COPD Workshop

Executive Summary

Introduction

COPD is now the third leading cause of death in the U.S., with > 130,000 people succumbing to the disease each year. Data from the Centers for Disease Control and Prevention (CDC) indicate that COPD affects 6% of the adult U.S. population aged 25 years and older. In 2010, there were nearly 1.5 million emergency department visits for COPD and 700,000 hospitalizations. COPD diagnosis and treatment have significantly improved in the past 15 years, but additional efforts to develop and implement effective preventive and therapeutic approaches are needed. Underscoring the importance of COPD to the health of the nation, the Senate Appropriations Committee in FY2012 encouraged the NHLBI "to work with community stake-holders and other Federal Agencies, including CDC, to develop a national action plan to respond to the growing burden of this disease". The NHLBI, the NIH component with primary responsibility for lung diseases, supports research and education activities on COPD and interacts with many of the various Federal Agencies and Institutes of the NIH that deal with this disease. In response to this congressional encouragement, the NHLBI hosted in Bethesda, Maryland, on May 3rd 2013, a forum of representatives from Federal government Agencies and Institutes (see list of participants below). The purpose of the meeting was to share information about current activities related to COPD and discuss opportunities for further cooperation and enhanced effectiveness of the federal response to this serious public health problem.

Workshop Description

The workshop began with a description of the characteristics of the disease, the population it affects, its relationship with present or past cigarette smoking, and the occurrence of 10-15% of the disease in individuals who have never smoked. Gender and racial/ethnic differences in mortality, including increases among Alaskan/Native American and non-Hispanic White women, were highlighted, and the frequent presence of a variety of co-morbid conditions was noted. Finally, the economic aspects of the disease were reviewed. COPD costs almost 30 billion annually in direct health care costs and another 20 billion in morbidity and mortality (2010 data). The disease frequently causes hospital and intensive care unit (ICU) admissions, and it decreases the likelihood of employment while increasing the likelihood of collecting social security disability insurance. Within this context, the convened group presented ongoing activities at each participating Agency/Institute, and discussed ways to develop and enhance collaborations to improve Federal efforts to deal with this disease.

Current COPD activities of Agencies/Institutes participating to the workshop.

Ongoing federal activities related to COPD are extensive and diverse, involving more than a dozen government agencies and offices. Key activities are summarized below.

Administration for Community Living (ACL)

ACL conducts annual surveys of older adults receiving services through the Older Americans Act (OAA). Approximately 11 million older adults (age 60+) receive one or more of these services. A sample of approximately 6,000 clients is asked, "Has a doctor ever told you that you have breathing or lung problems including emphysema, allergies or asthma?" While the question is not strictly restricted to COPD, it is noteworthy that in 2012, 42% individuals receiving home delivered meals through the OAA and 51% of individuals receiving case management services through the OAA responded "yes" to the question.

Assistant Secretary for Planning and Evaluation (ASPE)

  • ASPE partners with CMS and the National Quality Forum on developing healthcare quality performance measures for high impact medical conditions including COPD.
  • ASPE coordinates strategic planning across HHS for a variety of healthcare and public health issues that relate to COPD.

Centers for Disease Control and Prevention (CDC)

  • CDC coordinates state surveillance systems to monitor COPD prevalence.
  • CDC conducts a range of data collection systems that obtain information on COPD prevalence and risk factors, COPD associated use of ambulatory (physicians' offices, hospital outpatient clinics and emergency departments) and inpatient health care) and associated mortality. CDC analyzes data, interprets findings, and disseminates information from existing data collection e systems to increase public awareness about COPD.
  • CDC identifies states and local areas with the highest risks for COPD and greatest need for intervention program

Centers for Medicare & Medicaid Services (CMS)

  • CMS finances a major fraction of the costs of medical care for COPD through its Medicare program.
  • CMS has a longstanding interagency collaboration for National Coverage Determinations, including the on-going Long-term Oxygen Treatment Trial (LOTT Trial).
  • CMS measures, monitors and reports on COPD patient care outcomes, based on clinical practice guidelines, in the inpatient and ambulatory setting.

Environmental Protection Agency (EPA)

  • The EPA's research program is actively engaged in exposure assessment, clinical and population based research designed to understand factors that determine susceptibility to air pollutants including COPD.
  • EPA has developed an approved program for continuing medical education for physicians and health care professionals regarding ozone. Ozone can exacerbate the illness of persons living with COPD ( http://www.epa.gov/apti/ozonehealth/tools.html).
  • EPA is collaborating with CDC to develop a continuing medical education program on the health effects of ambient particulate matter.

Health Resources and Services Administration (HRSA) Federal Office of Rural Health Policy

  • HRSA Office of Rural Health Policy currently administers the Black Lung/Coal Miner Clinics Program, an approximately $7 million grant program aimed at minimizing the effects of respiratory impairment and improving the health status of active, inactive, and retired coal miners exposed to coal dust as a result of employment. The program also seeks to increase coordination with other services and benefits programs to meet the health-related needs of this population. The group of 15 grantees that comprises the program includes Federally Qualified Health Centers (FQHCs), freestanding clinics, state Departments of Health, and a mobile unit.
  • Research has shown there is a significant relationship between cumulative exposure to respirable coalmine dust and emphysema severity at autopsy, controlling for effects of smoking, race & age.
  • A number of grantees have engaged patients using various education and outreach strategies, national initiatives (Drive4COPD), COPD/asthma all-day clinics, home-based pulmonary rehabilitation, medication/inhaler adherence, patient navigators, books, support groups, and videos, reporting greater medication adherence and, in one instance, a reduction in re-hospitalizations related to COPD.

Indian Health Service (IHS)

  • IHS is strengthening the primary care system through the Improving Patient Care (IPC) program. Although current IPC services do not target COPD specifically, the patient centered medical home model promotes incorporating evidence-based guidelines and engaging patients and families in their care and treatment. This improves treatment COPD in the context of primary care for a population with a high prevalence of multiple chronic conditions.
  • Tobacco screening and tobacco cessation counseling are two of the 21 quality of care measures reported to Congress in the Government Performance and Results Act (GPRA) report. GPRA measures demonstrate that IHS tobacco cessation counseling rates have risen from 12 percent in 2006 to 35.2 percent in 2012. Twenty-one IHS pharmacies in eight Areas offer tobacco cessation programs where pharmacists provide behavioral counseling and prescribe tobacco cessation medications via a collaborative practice agreement. Seventy-six pharmacists are nationally credentialed by IHS to provide tobacco cessation services. Tobacco cessation medications are on the National Core Formulary (NCF).
  • In 2012 the IHS National Pharmacy and Therapeutics Committee (NPTC) added tiotropium to the NCF based on its role as a long-acting bronchodilator in the management of patients with COPD of moderate or greater severity. The NPTC also recommended against the use of salmeterol monotherapy in the management of COPD and other respiratory diseases.

National Cancer Institute (NCI)

  • NCI funds 10 Investigator-initiated grants (started in FY12) addressing COPD-relevant research.
  • In conjunction with NHLBI, NCI sponsored RFA HL11-002, which addresses common pathogenetic mechanisms of lung cancer and COPD. NCI’s goal is identifying mechanisms leading to lung cancer in the COPD setting, ultimately resulting in the development of markers for risk assessment and early detection as well as targets for early intervention
  • TCGA (The Cancer Genome Atlas) has performed a comprehensive genomic and epigenomic characterization of squamous cell lung cancer and adenocarcinoma. Some COPD data is being collected retroactively, and will be made available to the research community.
  • The National Lung Screening Trial (NLST), which demonstrated a 20% decrease in lung cancer mortality with helical CT in comparison to chest X-ray, and the Prostate Lung Colon Ovarian (PLCO) Screening Trial, which showed no difference in lung cancer mortality between chest X-ray and no screening, both have data and specimens available to the research community. History of COPD was captured in both studies and CT assessment of emphysema was performed in the NLST, providing a valuable resource for further investigations.

National Institute on Aging (NIA)

The NIA supports research on aging processes, age-related diseases, and special problems and needs of the aged. Currently, the NIA sponsors three active Funding Opportunity Announcements related to COPD:

  • "Aging Studies in the Pulmonary System" PA-13-255 (R01)
  • "Asthma in Older Adults" PA-10-263 (R01), PA-10-265 (R03), PA-10-264 (R21)
  • "Solid Organ Transplantation: Older Donors and Recipients" PA-13-030 (R01), PA-13-037 (R03), PA-13-038 (R21)

National Institute on Drug Abuse (NIDA)

  • NIDA supports an extensive portfolio on tobacco epidemiology, etiology, prevention, treatment and health services research.
  • The medical consequences of tobacco use, including COPD, are included in portions of this research as secondary outcomes.
  • Of note, the planned Population Assessment of Tobacco and Health Study (PATH Study) will include some measures of COPD, including self-report of diagnosis and treatment.

National Institute of Environmental Health Sciences (NIEHS)

  • NIEHS supports an extensive research portfolio on molecular causes of disease exacerbation, development of biomarkers of exposure, effect of particulate matter on lung and immune functions.
  • Gene and gene-environment studies are identifying novel loci associated with lung function, DNA methylation changes associated with tobacco exposure a panel of epigenetic markers (DNA methylation) of disease risk in smokers.
  • The NIEHS National Toxicology Program (NTP) carries out research to understand the environmental and occupational causes of obstructive lung diseases. The NTP conducts inhalation toxicity evaluations on a broad array of agents of health concern in animal models (e.g. volatiles, particulates, metals, mold, occupational mixtures, nanomaterials) and laboratory research on the biochemical and molecular mechanisms of toxicity of inhaled chemicals (e.g. artificial butter flavoring vapors and bronchiolitis obliterans).

National Heart, Lung, and Blood Institute (NHLBI)

  • NHLBI has a substantial basic science and clinical research portfolio related to COPD, which ranges from studies of pathogenetic mechanisms to research on COPD genetics and phenotypes (SPIROMICS, COPDGene).
  • NHLBI has also developed a translational portfolio that promotes the exploration of new therapies for the disease through the Specialized Centers of Clinically Oriented Research (SCCORs), the Centers for Advanced Diagnostics and Experimental Therapeutics (CADET), and Science Moving towArds Research Translation (SMARTT) programs. NHLBI is also conducting small- and large-scale clinical trials testing various therapies in COPD (sulphoraphane, azithromycin, statins, oxygen).
  • NHLBI in collaboration with several partners within and outside the Federal Agencies has implemented a nation-wide COPD awareness campaign aiming at increasing the visibility of the disease among persons at risk and healthcare providers.

National Institute for Occupational Safety and Health (NIOSH)

  • NIOSH conducts surveillance and epidemiological studies to: 1) identify industries, occupations, and exposures that are most associated with risk for developing work-related COPD; 2) assess the extent, severity, and burden of work-related COPD; and 3) guide the development of preventive strategies.
  • NIOSH also improves tools for detection of COPD. For example, the quality of spirometry is promoted through the NIOSH Spirometry Course Certification Program (http://www.cdc.gov/niosh/topics/spirometry/training.html), NIOSH activities enhance the detection of COPD and optimize the use of tools such as longitudinal spirometry (http://www.cdc.gov/niosh/topics/spirometry/spirola.html) and respiratory questionnaires.
  • NIOSH provides up-to-date guidance on tobacco and the workplace.

National Oceanic and Atmospheric Administration, (NOAA)

The National Weather Service's (NWS) mission broadly concerns the protection of life and property with respect to climate, weather, and water events. NOAA works to build a Weather-Ready Nation, looking to anticipate services that will be needed by an increasingly weather-sensitive society. The agency does not currently have a COPD-specific product, but provides the following capabilities and interests as it relates to pursuing cross agency collaborations on respiratory health, including understanding, predictability and risk prevention:

  • Provide weather, water, and climate products (e.g., data, models, and tools) that enable the health community to develop predictability tools for research, operations and decision support.
  • Offer guidance for the use of NWS products.
  • Leverage infrastructure, messaging and outreach capacities.
  • Gather requirements to improve NWS data and information that will support future products or services to assist our health federal partners in preventing/reducing COPD.

Office of the Assistant Secretary of Defense (OASD, Health Affairs)

VA/DoD has developed and implemented Clinical Practice Guidelines (CPG, https://www.qmo.amedd.army.mil/pguide.htm) that:

  • Are evidence-based and nationally recognized
  • Integrate clinical expertise and the current best evidence into point of care decision making
  • Improve clinical effectiveness with standardized decision making
  • Decrease variation in practice and promote the right care at the right time and in the right setting

Prevention of COPD is addressed by TRICARE Smoking Cessation Programs. These include:

  • www.Ucanquit2.org - Web-based tobacco cessation support
  • Quit Tobacco Make Everyone Proud - focusing on junior service members - smoking rates are higher than other service members
  • Regionally based tobacco cessation support lines

Office of the Assistant Secretary for Health (OASH)

  • Expansion of the Healthy People initiative to embrace five COPD objectives for the year 2020, one of which is in the developmental stage, i.e., being without baseline data so far and an established 2020 target. The remaining four objectives all have data and targets, so their progress over the decade can be measured.
  • ODPHP convenes monthly Progress Review webinars to inform the HHS Assistant Secretary for Health and others about the status of two of the 42 Topic Areas of Healthy People 2020 taken in turn. The Progress Review to be held in October 2013 will feature Respiratory Diseases and Sleep Health. COPD will be a subject of discussion during the Progress Review.
  • As resources allow, ODPHP accommodates requests for participation in conferences and other kinds of assemblies held in locations across the country that are devoted to subjects of public health concern, such as COPD.

COPD future directions and opportunities for collaborations.

The participants at the workshop highlighted specific areas that would benefit from the development of collaborations. Three thematic areas were identified: disease prevention, ascertainment, and diagnosis/treatment. The following topics within these areas illustrate goals that might be accomplished more effectively or efficiently by coordination of efforts among Federal Agencies.

Disease Prevention

Communicate the deleterious health effects of cigarette smoking and tobacco products to the public. Continue efforts to examine the etiology, prevention, and treatment of tobacco/nicotine dependence to help reduce the public health burden of COPD.

Continue to employ culturally appropriate tobacco cessation strategies, tailoring preventive messages to the population at risk (i.e. rural populations, miners, active duty or retired military personnel).

Promote tobacco free living and initiatives in support of tobacco free environments.

Integrate smoking cessation programs with smoke-related diseases (COPD, CVD, cancer) prevention messages.
Define and address the role of health disparities and social determinants in COPD.
Better define the connection between COPD and the use of tobacco and other substances.
Develop, demonstrate, and document the effectiveness of workplace-based, comprehensive programs for protection against work-related COPD and promotion of workers' respiratory health.

Better define the connection between COPD and indoor (i.e. cook stoves) and outdoor pollution especially in developing countries and in women and younger individuals.

Integrate research in gene-environment interactions in COPD prevention

Continue to conduct surveillance and epidemiological studies to understand the changing burden of illness and patterns of risk factors for COPD in an era of declining tobacco use.

Disease ascertainment

Quantify lung function, functional impairment, and physical activity limitation as population-wide predictors of mortality.

Continue to monitor the progress of the Healthy People 2020 objectives, including those related to COPD.

Promote achievement of the Healthy People 2020 COPD targets, for instance, through the medium of one of OASH one-and-one-half hour Spotlight on Health webinars.

Continue to increase public awareness of the importance of social determinants of health and of the need to further reduce population disparities, which occur in a variety of fields, including COPD.

Use a standardized definition of COPD in data collection.

Continue and expand diversified data collection and surveillance systems to obtain a comprehensive picture of COPD prevalence, morbidity, and mortality across different US populations.

Facilitate the correlation of epidemiological data on COPD with other data collected by Institutes/Agencies, ranging from type and quality of health care delivery to geographic, seasonal, environmental, and atmospheric variables.

Integrate occupational exposure surveillance with surveillance of COPD prevalence, morbidity, and mortality in both ever smokers and never smokers to clarify the relationship of occupational exposures with this disease.

Investigate the role of the indoor environment in the pathogenesis and progression of COPD.

Identify additional risk factors for COPD initiation and progression.

Develop models and tools that communities can use to assess health risks such as exacerbation of COPD caused by exposure to air pollutants.
Improve performance measures for healthcare quality related to COPD, including areas such as care access and affordability and quality of life for COPD patients.

Develop uniform electronic health record (EHR) definitions and standard measurements of COPD, and expand use of EHR data to improve COPD management/treatment adherence among patients.

Identify policies in worksites, health systems, and at community levels that would facilitate the identification of persons with COPD and/or reduce COPD risk.

COPD Diagnosis/Treatment

Promote a coordinated, patient-centered approach to the management and measurement of COPD patient care, recognizing the likelihood of multiple co-existing medical co-morbidities and emphasizing goals of functional independence, patient satisfaction and improved quality of life.

Develop innovative programs, such as bundling of COPD patient care, to improve management of multiple co-existing medical co-morbidities, care coordination and care efficiencies.

Develop policies or program-related initiatives that target individuals living in rural areas, who may not have equal access to specialized care or pulmonary rehabilitation services.

Promote the Global Initiative for Chronic Obstructive Lung Disease (GOLD) treatment guidelines based on stage of COPD and increase provider education on national guidelines for the prevention and treatment of COPD.

Develop standardized diagnostic and treatment guidelines applicable to different populations (i.e. rural populations, miners, active duty or retired military) while providing knowledge resources to the healthcare providers that serve these special populations.

Better understand COPD in older individuals who likely have one or more geriatric syndromes (e.g., falls, incontinence, frailty, sarcopenia) and/or multiple chronic conditions for which they may receive multiple treatments.

Develop management approaches that incorporate important geriatric outcomes such as functional capacity, cognitive status, sensory function, mood, and social support, and that incorporate patient and family preferences for these outcomes.

Manage COPD in the context of multiple chronic conditions with focus on treatment priority, interaction, and efficacy/time to benefit.

Consider the vulnerability of older COPD patients to respiratory infections (viral and bacterial) due to age-related alterations in the respiratory and immune systems.

Conduct research on the prevention (including vaccination) and treatment of respiratory infections in older COPD patients to reduce incidence, spread/contagiousness, and improve outcomes.

Evaluate the suitability of older COPD patients to lung volume reduction surgery for end-stage COPD and test its efficacy in this population.

Address care and decision-making regarding palliative and end-of-life care of older COPD patients including cessation of life-assisting interventions (e.g., mechanical ventilation). Develop guidelines for nursing home and palliative care in COPD.

Evaluate the interplay among muscle wasting/sarcopenia, COPD, and nutritional status.

Within the VA/DoD system, increase utilization of VA/DoD Clinical Practice Guidelines for treating COPD, and update these as new evidence becomes available.

Continue Agencies/Institutes collaborations to help establish, as in the recent past, national coverage determinations by CMS.

Validate intermediary outcomes (through biomarkers qualification) to establish and improve measures of patient responses to treatments, also based on gene-gene interactions.

Establish performance measures/quality measures based on clinical practice guidelines.

Define and establish guidelines for pulmonary rehabilitation.


Summary and Developments

The workshop participants discussed ways to develop and enhance collaborations to improve the federal response to this disease. Given the severity and magnitude of the COPD problem, the group saw merit in the establishment, through appropriate channels, of a national action plan with an associated organizational structure.

As an immediate action, the federal representatives of the Agencies/Institutes participating in the workshop agreed to put in place a system of web links on their own web pages to enable patients and healthcare providers to learn about activities ongoing at other Federal Agencies/Institutes related to COPD. These web links will connect existing pages of various Agencies and Institutes of the Federal Government and provide interested end-users a more comprehensive picture of ongoing COPD federal activities. The NHLBI Office of Communications will coordinate this effort.

Federal representatives of the Agencies/Institutes participating in the workshop will convene again through teleconference within one year to report on progress and discuss with external, non-federal stakeholders options for developing a national action plan to respond to the growing burden of COPD.


Workshop Participants

Administration for Community Living (ACL)
Robert Hornyak MS
Michelle Washko, PhD

Assistant Secretary for Planning and Evaluation (ASPE)
Kea Turner, MPH,MAE

Centers for Disease Control and Prevention (CDC)
Wayne H. Giles, MD, MS

Centers for Medicare & Medicaid Services (CMS)
Alan Levitt MD
Charles Padgett RN

Environmental Protection Agency (EPA)
Kathy Sykes PhD

Food and Drug Administration(FDA)
Lydia I Gilbert-McClain, MD, FCCP

Health Resources and Services Administration (HRSA)
Nadia Ibrahim, MA, LGSW
Ann Ferrero, MPH

Indian Health Service (IHS)
Susan V. Karol, MD, FACS

National Cancer Institute (NCI)
Eva Szabo, MD
Nonniekaye Shelburne, CRNP, MS, AOCN

National Center For Health Statistics (NCHS)
Jennifer H. Madans, PhD

National Institute on Aging (NIA)
Basil Eldadah, MD

National Institute on Drug Abuse (NIDA)
Jeffrey D. Schulden, MD

National Institute of Environmental Health Sciences (NIEHS)
Aubrey K. Miller, MD, MPH

National Institutes of Health (NIH)
Office of the Director (OD)
Rashada C. Alexander, PhD

National Heart, Lung, and Blood Institute (NHLBI, organizing)
James P. Kiley, PhD
Thomas L. Croxton, PhD, MD
Monique Ndenecho
Antonello Punturieri, MD, PhD
Lisa A. Postow, PhD
Lisa Viviano Webber, BSN, RN

National Institute for Occupational Safety and Health (NIOSH)
Ainsley Weston, PhD
David Weissman, MD

National Oceanic and Atmospheric Administration, (NOAA)
David S. Green, PhD
Jamese D. Sims, PhD

National Science Foundation (NSF)
Sohi Rastegar, PhD

Office of the Assistant Secretary for Health (OASH)
Don Wright, MD, MPH

Office of the Assistant Secretary of Defense (OASD, Health Affairs)
Robin Marzullo, RN, MS

Office of the Surgeon General
Mary Beth Bigley, DrPH, MSN, ANP

U.S. Department of Veterans Affairs (VA)
Marta L. Render, MD


References:

http://www.cdc.gov/mmwr/pdf/wk/mm6146.pdf
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3707177/pdf/chest_144_1_284.pdf

Last Updated: November 2013

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