Author + information
- Published online October 28, 2014.
- Donna K. Arnett, MSPH, PhD,
- Richard A. Goodman, MD, MPH∗,
- Jonathan L. Halperin, MD,
- Jeffrey L. Anderson, MD,
- Anand K. Parekh, MD, MPH and
- William A. Zoghbi, MD
- ACC/AHA Clinical Practice Guidelines
- health care
- multiple chronic conditions
Cardiovascular disease, the leading cause of death in the United States and worldwide, accounts for substantial suffering and healthcare−related expenditures (1–3). For more than 30 years, the American Heart Association (AHA) and the American College of Cardiology (ACC) have partnered with other organizations to translate the best available scientific evidence into clinical practice guidelines (CPGs) for cardiovascular conditions. These efforts reflect a shared vision and responsibility for using scientific evidence and the expert clinical opinion of leaders in the field to develop recommendations for healthcare providers. These CPGs, based on systematic methods to evaluate and classify evidence, have provided the cornerstones for delivering quality cardiovascular care.
CPGs are essential tools for optimizing care for patients with cardiovascular conditions. Enhancing the utility of CPGs requires that the development process reflect the evolution of relevant foundational domains, such as biomedical discoveries, public policy, clinical care systems, and epidemiological knowledge. Dynamic changes in these domains pose substantial implications for organizations that develop CPGs. Among these changes is the increasing prevalence of ≥2 chronic conditions among individual Americans, estimated to be present in more than one quarter of adults (4). In the large population of Medicare beneficiaries, the prevalence of persons with multiple chronic conditions is considerably greater: more than two thirds (68%) have ≥2 chronic conditions, and 14% have ≥6 chronic conditions (5,6).
Comorbidities and CPGs for Cardiovascular Conditions
CPGs jointly developed by the AHA/ACC are cardiovascular disease−specific documents focused on the prevention, diagnosis, and management of conditions such as ischemic heart disease, heart failure, and atrial fibrillation. These CPGs often contain considerations for special factors (e.g., older adults) and common problems affecting pharmacokinetics (e.g., renal impairment). For example, the 2014 CPG on atrial fibrillation (7) highlights special considerations for acute myocardial infarction, pregnancy, hyperthyroidism, and other conditions. With the exception of the CPGs on atrial fibrillation and heart failure (7,8), CPGs have not systematically incorporated recommendations on how common comorbidities that accompany a specific cardiovascular condition might affect the care and management of patients with comorbidities.
With progressive growth in the size of the older adult population and the increased prevalence of comorbidities in patients with cardiovascular conditions, CPGs need to address the complex implications of comorbidity for the care of cardiovascular patients. This issue is particularly important for some older adults, because clinicians must select from among treatments on the basis of evidence for risk and benefit (9). Recognizing this imperative, the AHA/ACC have taken steps to address comorbidities more consistently in CPGs, including actions resulting from the U.S. Department of Health and Human Services initiative on multiple chronic conditions (10). The centerpiece of this initiative—a strategic framework on multiple chronic conditions—explicitly focuses on the need for developers of CPGs to address chronic conditions (11). Accordingly, the Department of Health and Human Services and the Institute of Medicine convened a stakeholder meeting that included the AHA/ACC to identify core principles for CPGs in the effective management of people with multiple chronic conditions and related actions that might be taken by developers of CPGs (12). At the request of the AHA/ACC, the Centers for Medicare & Medicaid Services (CMS) provided the data for analysis of the most common comorbidities in Medicare beneficiaries with selected cardiovascular conditions for potential use in development of CPGs.
Prevalence of Comorbidities Among Patients Presenting With Index Cardiovascular Conditions
To assess the frequency of comorbidities, the 10 most common comorbid conditions among Medicare beneficiaries were identified using CMS administrative enrollment and claims data (13) for 4 index cardiovascular conditions: ischemic heart disease, heart failure, atrial fibrillation, and stroke. The Medicare population was limited to beneficiaries ≥65 years of age who were continuously enrolled in Medicare fee-for-service (both Parts A and B) during 2012. Beneficiaries enrolled in Medicare Advantage during 2012 were excluded because claims data were unavailable for these beneficiaries. Beneficiaries who died during the year were included up to the date of death.
For each of the 4 index cardiovascular conditions, comorbidity was determined with the following conditions: acquired hypothyroidism, acute myocardial infarction, Alzheimer’s disease or dementia, anemia, arthritis (osteoarthritis and rheumatoid arthritis), asthma, atrial fibrillation, autism spectrum disorder, benign prostatic hyperplasia, breast cancer (female and male), cataract, chronic kidney disease, colon cancer, chronic obstructive pulmonary disease, depression, diabetes mellitus, endometrial cancer, glaucoma, heart failure, hip or pelvic fracture, hyperlipidemia, hypertension, ischemic heart disease, lung cancer, osteoporosis, prostate cancer, schizophrenia and other psychotic disorders, or stroke. A Medicare beneficiary was considered to have a chronic condition if the CMS administrative data included a claim indicating that the beneficiary received service or treatment for the specific condition. Detailed information on the identification of chronic conditions is available from the CMS Chronic Conditions Data Warehouse (13).
Table 1 shows the 10 most common comorbidities for each index cardiovascular condition for beneficiaries ≥65 years of age in 2012 (13). The numbers of Medicare beneficiaries with the 4 index cardiovascular conditions were 8,678,060 with ischemic heart disease, 4,366,489 with heart failure, 2,556,839 with atrial fibrillation, and 1,145,719 with stroke. Two conditions that are major cardiovascular risk factors—hypertension and hyperlipidemia—constitute the most frequent dyad. Hypertension, hyperlipidemia, and ischemic heart disease were the 3 most prevalent comorbidities for patients with heart failure, atrial fibrillation, and stroke, whereas hypertension, hyperlipidemia, and diabetes mellitus were the most prevalent comorbidities in those with ischemic heart disease; however, arthritis, anemia, chronic obstructive pulmonary disease, and Alzheimer’s disease also appeared.
Table 2 lists the top 5 most prevalent dyad and triad comorbidities for beneficiaries ≥65 years of age with at least 2 (for dyads) or 3 (for triads) chronic conditions. Combinations of high cholesterol, high blood pressure, and ischemic heart disease were most frequently represented in the dyads and triads, with diabetes mellitus and arthritis completing the remaining prevalent combinations (14).
Implications and Future Directions in the Development of CPGs
Two general, but important, points emerge from the CMS data. First, a beneficiary with cardiovascular disease but without at least 1 comorbid chronic condition is the exception rather than the rule. Second, whereas common risk factors such as hypertension and hyperlipidemia are associated with the index cardiovascular conditions, the index conditions are associated with a constellation of comorbidities, the pathophysiology of which may be distinct from the index condition and for which prevalence increases with age or other factors.
Organizations that develop CPGs must now consider comorbidities during the development process for disease-specific CPGs. For high-prevalence index conditions, few CPGs address comorbidities (15), and even fewer provide guidance for patients with specific combinations of diseases. Managing patients with multiple conditions is more complex than managing patients with a single disease, and the presence of multiple conditions increases challenges for healthcare providers and patients. Comorbidities may constitute barriers to adherence to CPGs, and caring for patients with multiple comorbidities can affect patient safety if recommendations for diagnosis and treatment in one CPG conflict with those for another condition (16). The complexity of various regimens for multiple comorbidities adds to the difficulty in patient management and assessment of clinical outcomes (17). Furthermore, limited attention has been given to the physical, cognitive, social, psychological, and financial implications of managing comorbidities. Involving patients in the CPG development process, which the AHA/ACC recently initiated, is critically important to fully appreciate patient perspectives (18,19).
Currently, there are important challenges in addressing common comorbidities in the development and implementation of CPGs. Patients with comorbidities are often excluded from clinical trials, limiting the evidence with which to make generalizable recommendations (20–22). This concern is explicitly addressed in the Department of Health and Human Services strategic framework, which emphasizes the need for external validation of clinical and drug approval trials by ensuring that persons with multiple comorbid conditions are not excluded unnecessarily (11). In support of this objective, the U.S. Food and Drug Administration now instructs that a regular part of its assessment of clinical trials incorporate a closer examination of the populations to be included in such trials and presumes that drug developers include patients with multiple comorbid conditions (23). The increasing use of electronic health records and clinical registries would also allow a longitudinal evaluation of the management strategies and clinical outcomes of patients with cardiovascular disease and comorbidities, which often is not afforded by randomized clinical trials. Other challenges to addressing comorbidities in CPGs are the number of comorbidities to be considered and those that may be underreported, such as obesity, depression, significant cognitive impairment, and frailty, several of which become increasingly common with age and affect patient management and outcome. Thus, given the current lack of trial evidence and the complexity of treating patients with common cardiovascular comorbidities, CPGs may, in certain instances, need to be more nuanced to account for clinical judgment and acknowledge the role of individualized, patient-centered decision making in implementation.
In the future, the AHA/ACC CPGs will explicitly discuss the applicability and quality of recommendations for the most frequent combinations of comorbidities that accompany cardiovascular conditions. An important step in this direction is the collaboration between the AHA/ACC and the Department of Health and Human Services that includes development of comorbidity data for selected cardiovascular conditions that, in turn, can be included and addressed in CPGs such as the most recent guidelines on atrial fibrillation and heart failure (7,8). The AHA/ACC aim to partner with various organizations to determine how best to highlight and address the complex issues arising from comorbidities in clinical medicine.
Author Relationships With Industry and Other Entities (Relevant)∗—AHA/ACC/HHS Strategies to Enhance Application of Clinical Practice Guidelines in Patients With Cardiovascular Disease and Comorbid Conditions (March 2014)
|Committee Member||Employment||Consultant||Speakers Bureau||Ownership/Partnership/Principal||Personal Research||Institutional, Organizational, or Other Financial Benefit||Expert Witness|
|Donna K. Arnett|
(Past President, AHA)
|University of Alabama School of Public Health, Department of Epidemiology—Professor and Chair||None||None||None||None||None||None|
|Richard A. Goodman|
|U.S. Department of Health and Human Services, Office of the Assistant Secretary for Health, and the National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention—Senior Medical Advisor||None||None||None||None||None||None|
|Jonathan L. Halperin|
(ACC/AHA Task Force on Practice Guidelines)
|The Cardiovascular Institute, Mount Sinai Medical Center, Division of Cardiology—Professor of Medicine||None||None||None||None||None||None|
|Jeffrey L. Anderson|
(ACC/AHA Task Force on Practice Guidelines)
|Intermountain Heart Institute, Intermountain Healthcare—Associate Chief of Cardiology||None||None||None||None||None||None|
|Anand K. Parekh|
|U.S. Department of Health and Human Services—Deputy Assistant Secretary for Health (Science and Medicine)||None||None||None||None||None||None|
|William A. Zoghbi|
(Past President, ACC)
|Houston Methodist DeBakey Heart and Vascular Center—William L. Winters Chair of Cardiovascular Imaging; Houston Methodist Hospital—Director, Cardiovascular Imaging||None||None||None||None||None||None|
This table represents the relationships of committee members with industry and other entities that were determined to be relevant to this document. These relationships were reviewed and updated in conjunction with all meetings and/or conference calls of the writing committee during the document development process. The table does not necessarily reflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents ownership of ≥5% of the voting stock or share of the business entity, or ownership of ≥$10,000 of the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% of the person’s gross income for the previous year. Relationships that exist with no financial benefit are also included for the purpose of transparency. Relationships in this table are modest unless otherwise noted. Please refer to http://www.cardiosource.org/Science-And-Quality/Practice-Guidelines-and-Quality-Standards/Relationships-With-Industry-Policy.aspx for definitions of disclosure categories or additional information about the ACC Disclosure Policy for Writing Committees.
According to the ACC/AHA, a person has a relevant relationship IF: a) the relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or issue addressed in the document; or b) the company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document, or makes a competing drug or device addressed in the document; or c) the person or a member of the person’s household, has a reasonable potential for financial, professional, or other personal gain or loss as a result of the issues/content addressed in the document.
ACC indicates American College of Cardiology; AHA, American Heart Association; and HHS, U.S. Department of Health and Human Services.
↵∗ For transparency, the authors' comprehensive disclosure information is available as an online supplement (http://jaccjacc.cardiosource.com/acc_documents/Multiple_Comorbidities_Article_Comprehensive_RWI_Table.pdf).
↵∗ The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the U.S. Centers for Disease Control and Prevention.
This document was approved by the American College of Cardiology Board of Trustees, the American Heart Association Science Advisory and Coordinating Committee, and the U.S. Department of Health and Human Services in July 2014.
The American College of Cardiology requests that this document be cited as follows: Arnett DK, Goodman RA, Halperin JL, Anderson JL, Parekh AK, Zoghbi WA. AHA/ACC/HHS strategies to enhance application of clinical practice guidelines in patients with cardiovascular disease and comorbid conditions: from the American Heart Association, American College of Cardiology, and U.S. Department of Health and Human Services. J Am Coll Cardiol. 2014;64:1851–6.
This article is copublished in Circulation.
Copies: This document is available on the World Wide Web sites of the American College of Cardiology (www.acc.org), and the American Heart Association (my.americanheart.org). For copies of this document, please contact Elsevier Inc. Reprint Department, fax 212-462-1935, e-mail .
Permissions: Modification, alteration, enhancement and/or distribution of this document are not permitted without the express permission of the American College of Cardiology. Requests may be completed online via the Elsevier site (http://www.elsevier.com/authors/obtainingpermission-to-re-use-elseviermaterial).
- American Heart Association, Inc., and the American College of Cardiology Foundation
- Go A.S.,
- Mozaffarian D.,
- Roger V.L.,
- et al.
- Hoyert DL, Xu JQ. Deaths: preliminary data for 2011. National Vital Statistics Reports. Centers for Disease Control and Prevention. 2011. Available at: http://www.cdc.gov/nchs/data/nvsr/nvsr61/nvsr61_06.pdf. Accessed July 9, 2013.
- Mensah G.A.,
- Brown D.W.
- ↵Centers for Medicare and Medicaid Services. Chronic Conditions among Medicare Beneficiaries, Chartbook, 2012 ed. 2012. Available at: http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Chronic-Conditions/Downloads/2012Chartbook.pdf. Accessed March 5, 2014.
- January C.T.,
- Wann L.S.,
- Alpert J.S.,
- et al.
- Yancy C.W.,
- Jessup M.,
- Bozkurt B.,
- et al.
- ↵U.S.Department of Health and Human Services. HHS Initiative on Multiple Chronic Conditions. 2014. Available at: http://www.hhs.gov/ash/initiatives/mcc/. Accessed March 5, 2014.
- ↵U.S.Department of Health and Human Services. Multiple Chronic Conditions—A Strategic Framework: Optimum Health and Quality of Life for Individuals with Multiple Chronic Conditions. 2010. Available at: http://www.hhs.gov/ash/initiatives/mcc/mcc_framework.pdf. Accessed March 5, 2014.
- Goodman R.A.,
- Boyd C.,
- Tinetti M.E.,
- et al.
- ↵Chronic Conditions Data Warehouse. Unpublished data from the Office of Information Products and Data Analytics, Centers for Medicare and Medicaid Services. 2014. Available at: http://www.ccwdata.org. Accessed January 1, 2014.
- ↵Centers for Medicare & Medicaid Services. Chronic conditions overview. 2014. Available at: http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Chronic-Conditions/index.html. Accessed May 9, 2014.
- Piette J.D.,
- Kerr E.A.
- Bayliss E.A.,
- Bonds D.E.,
- Boyd C.M.,
- et al.
- U.S.Food and Drug Administration. Digital Infuzion, Inc. U.S. Food and Drug Administration (FDA) inventory of clinical trials protocols and clinical study data. 2011. Available at: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/ConductingClinicalTrials/UCM309552.pdf. Accessed April 9, 2014.
- ↵U.S.Food and Drug Association. Development & approval process (drugs). 2014. Available at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ConductingClinicalTrials/ucm379576.htm. Accessed February 17, 2014.
- Comorbidities and CPGs for Cardiovascular Conditions
- Prevalence of Comorbidities Among Patients Presenting With Index Cardiovascular Conditions
- Implications and Future Directions in the Development of CPGs
- Author Relationships With Industry and Other Entities (Relevant)∗—AHA/ACC/HHS Strategies to Enhance Application of Clinical Practice Guidelines in Patients With Cardiovascular Disease and Comorbid Conditions (March 2014)
- Reviewer Relationships With Industry and Other Entities (Relevant)—AHA/ACC/HHS Strategies to Enhance Application of Clinical Practice Guidelines in Patients With Cardiovascular Disease and Comorbid Conditions (March 2014)