This Article Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Rao, S. V. Search for Related Content PubMed PubMed Citation Articles by Rao, S. V. Related Collections Related Articles

EDITORIAL COMMENT

Scaling New Heights in Quality Improvement

The PINNACLE (Practice Innovation And Clinical Excellence) Program^_*

Duke Clinical Research Institute, Durham, North Carolina

^_* Reprint requests and correspondence: Dr. Sunil V. Rao, The Duke Clinical Research Institute, 508 Fulton Street (111A), Durham, North Carolina 27705 (Email: sunil.rao{at}duke.edu).

Key Words: performance measure • quality of care • compliance • outpatient

In this issue of the Journal, the paper by Chan et al. (2) describes the American College of Cardiology's efforts to measure and improve the quality of cardiovascular care delivered in the outpatient setting by the PINNACLE (Practice Innovation And Clinical Excellence) program. This is timely because there has been an increase in the numbers of outpatients with cardiovascular diagnoses over time (3), there will be increased focus on improving the care that these patients receive, and this is the first national outpatient cardiac quality improvement (QI) program in the U.S. The data reported by Chan et al. (2) can be viewed as either good news or bad news. Adherence to some performance measures, such as blood pressure assessment for patients with congestive heart failure, was very high (>96%). Compliance with other measures was also reasonably high: prescription of drug therapy to lower low-density lipoprotein cholesterol and antiplatelet therapy for patients with coronary artery disease was >80%. In contrast, there appears to be considerable room for improvement in referring appropriate patients to cardiac rehabilitation and screening patients for diabetes mellitus.

While these data are interesting and important, the publication of the PINNACLE data has greater implications for the future of QI. This paper represents a "first look" at the data from only 27 cardiology practices that chose to participate in the PINNACLE program. Therefore, an important message of this paper is the potential that this registry represents—part of a portfolio of QI programs that span the continuum of care from the inpatient to the outpatient setting. Using the currently available QI tools, a patient with ischemic cardiomyopathy can have practically every aspect of their care examined for adherence to practice guidelines. For example, during an inpatient admission for acute coronary syndromes, data regarding their management can be entered into the NCDR ACTION–Get With The Guidelines Registry. If they undergo PCI, these data can be entered into the NCDR CathPCI Registry. If they undergo coronary artery bypass graft surgery, the data can be entered into the Society for Thoracic Surgeons database. If they receive an implantable cardioverter-defibrillator, the data can be entered into the NCDR ICD Registry. If they undergo carotid artery stenting, the data can be entered into the NCDR CARE Registry. Now, the quality of the care they receive after hospitalization can be evaluated using the PINNACLE program.

What, then, is missing from the QI tool kit? In a word: completeness. Data from registries are unlike data from clinical trials. Clinical trial data are prospectively collected, carefully monitored and cleaned for completeness and errors, and includes patient identifiers and follow-up. The drawbacks are well known. Trials have exclusion criteria and may not represent some patient subgroups or those who are unable to consent. Although registries include patients that may be excluded from clinical trials, there are limitations to registry data that likely lead to overestimation of adherence to care processes and underestimation of adverse outcomes. First, participation in most QI registries is voluntary; not all practices or hospitals are represented. Practices and providers who choose to participate in these QI efforts are likely different from those who choose not to participate. The former may, in fact, deliver higher quality of care simply because they are interested in measuring it. So while we can take some reassurance from the rates of compliance with guideline-recommended therapies described in the paper by Chan et al. (2), we should not become complacent, because they likely are overestimates of compliance. Second, while random data checks are implemented in some registries, the rate of missing may be relatively high for some data fields. That may be compounded by the fact that the data are often entered retrospectively from chart review. To account for this, the definition of certain adverse events such as bleeding is usually constructed to include data elements that would appear in the patient's chart (e.g., transfusion). If a site does not routinely document bleeding events that do not require transfusion, then these events are not included in the registry data. This is evidenced by a lower rate of peri-PCI bleeding seen in registries compared with in clinical trials (4,5). Similarly, the rate of peri-PCI myocardial infarction does not appear to be a reliable performance measure in PCI registries where the collection of post-procedure cardiac markers is not mandated (6). Third, most QI registries do not contain patient identifiers or long-term outcomes because to do so would require patient consent and approval by the institutional review board of every participating site. Instead, they necessarily must sacrifice granularity for scope—a large amount of less specific data from many sites. Finally, although the quality of care a patient receives can be examined comprehensively, doing so requires participation in several registries (6 in the example cited above). Because hospitals and practices often pay to participate in QI registries, enrolling in every available one may be cost prohibitive.

How then do we move forward in a world where QI has all but become a mandate? The answer lies in 3 principles: consistency, completeness, and connectivity. These concepts have been outlined broadly by other authors (7) but cannot be emphasized enough. As mentioned above, the definitions for similar data elements differ between clinical trials and registries. That runs counter to the efforts of both the professional societies and academic groups to standardize definitions (8–10). Consistency across trials and registries would facilitate QI by enabling an "apples to apples" assessment of the safety and effectiveness of evidence-based therapies. The American College of Cardiology has recently undertaken an effort to standardize definitions for data elements that are common across the NCDR QI programs. However, as long as participation in QI registries is voluntary, there will never be a complete picture of care processes. Some have called for mandatory participation in registries (7), and although this is unlikely to be mandated explicitly, the health care reform bill does contain financial incentives for hospitals and providers to participate in QI efforts. For example, the PINNACLE program is an approved registry for the Physician Quality Reporting Initiative, a program by the Centers for Medicare and Medicaid Services that provides incentive payments to eligible providers who report satisfactory performance on certain quality measures. Providers that participate in PINNACLE have incentive, therefore, to provide complete information on performance measures and increase compliance with them to qualify for higher payment. These financial incentives make it likely that the number of participants in QI registries will increase over time, and the data flowing into the registries will multiply at an exponential rate. However, more information does not necessarily mean better information. The constant "river of data" that comes from the registries will have greater value if there is a system of data monitoring and connectivity across registries. It may be easier for a provider, practice, or hospital to participate in QI efforts if the data from a single patient, like that described in the preceding text, can be simultaneously entered into all of the relevant QI programs. At the very least, data fields that are common across data collection forms, such as age, sex, medical history, and so forth, should be autopopulated in several databases. This data infrastructure can also be applied to prospective clinical investigations in which the registry data collection tool can serve as a backbone for case report forms. Such an effort is already under way (11) and has the potential to improve the efficiency of both QI programs and clinical trials by avoiding the development of a new data collection tool for every new registry or trial. Answering clinical or care process questions can then be achieved by going to the "river of information" to obtain the relevant data. This is a lofty goal to be sure, and requires a re-engineering of both clinical trial and QI operations. It also requires substantial investment and commitment from professional societies, hospitals, providers, clinical investigators, and governmental and private sponsors of research.

Until now, QI programs have provided snapshots of clinical care. The PINNACLE program serves as a reminder that clinical care does not occur in snapshots; it is longitudinal, interrelated, and spans across specialties and diagnoses. In this context, current QI efforts fall somewhat short, but with the PINNACLE program, many of the necessary pieces are in place to address quality comprehensively. The task now is to tie them together. By addressing an area of QI that has not been previously dealt with, the PINNACLE program is a step forward and scales new heights, but more work remains to be done if we are to reach the summit of quality.

	Footnotes

 
Dr. Rao has received research funding from Cordis Corp., Momenta Pharmaceuticals, and Portola Pharmaceuticals; and is a consultant for and receives honoraria from Sanofi-Aventis, Bristol-Myers Squibb, The Medicines Company, Terumo Corp., and AstraZeneca.

^_* Editorials published in the Journal of the American College of Cardiology reflect the views of the authors and do not necessarily represent the views of JACC or the American College of Cardiology.

	References

Top References

 
1. United States. Congress. Senate. 111th Congress nS Health Care and Education Affordability Reconciliation Act of 2010 2010.

2. Chan PS, Oetgen WJ, Buchanan D, et al. Cardiac performance measure compliance in outpatients: the American College of Cardiology and National Cardiovascular Data Registry's PINNACLE (Practice Innovation And Clinical Excellence) program J Am Coll Cardiol 2010;56:8-14.[Abstract/Free Full Text]

3. Lloyd-Jones D, Adams RJ, Brown TM, et al. Heart disease and stroke statistics—2010 update: a report from the American Heart Association Circulation 2010;121:e46-e215.[Free Full Text]

4. Mehta SK, Frutkin AD, Lindsey JB, et al. Bleeding in patients undergoing percutaneous coronary intervention: the development of a clinical risk algorithm from the National Cardiovascular Data Registry Circ Cardiovasc Interv 2009;2:222-229.[Abstract/Free Full Text]

5. Stone GW, McLaurin BT, Cox DA, et al. Bivalirudin for patients with acute coronary syndromes N Engl J Med 2006;355:2203-2216.[CrossRef][Medline]

6. Wang TY, Peterson ED, Dai D, et al. Patterns of cardiac marker surveillance after elective percutaneous coronary intervention and implications for the use of periprocedural myocardial infarction as a quality metric: a report from the National Cardiovascular Data Registry (NCDR) J Am Coll Cardiol 2008;51:2068-2074.[Free Full Text]

7. Butler J, Kalogeropoulos A. Registries and health care quality improvement J Am Coll Cardiol 2009;54:1290-1292.[Free Full Text]

8. Cannon CP, Battler A, Brindis RG, et al. American College of Cardiology key data elements and definitions for measuring the clinical management and outcomes of patients with acute coronary syndromes. A report of the American College of Cardiology Task Force on Clinical Data Standards (Acute Coronary Syndromes Writing Committee). J Am Coll Cardiol 2001;38:2114-2130.[Free Full Text]

9. Cutlip DE, Windecker S, Mehran R, et al. Clinical end points in coronary stent trials: a case for standardized definitions Circulation 2007;115:2344-2351.[Abstract/Free Full Text]

10. Rao SV, Eikelboom J, Steg PG, et al. Standardized reporting of bleeding complications for clinical investigations in acute coronary syndromes: a proposal from the academic bleeding consensus (ABC) multidisciplinary working group Am Heart J 2009;158:881-886.[CrossRef][Web of Science][Medline]

11. NIH Project number 1RC2HL101512-01: ACC/Duke Partnership for a National Cardiovascular Data Infrastructure http://projectreporter.nih.gov/project_description.cfm?projectnumber=1RC2HL101512-01 2009Accessed April 10, 2010.

Related Articles

Cardiac Performance Measure Compliance in Outpatients: The American College of Cardiology and National Cardiovascular Data Registry's PINNACLE (Practice Innovation And Clinical Excellence) Program

Paul S. Chan, William J. Oetgen, Donna Buchanan, Kristi Mitchell, Fran F. Fiocchi, Fengming Tang, Philip G. Jones, Tracie Breeding, Duane Thrutchley, John S. Rumsfeld, and John A. Spertus
J. Am. Coll. Cardiol. 2010 56: 8-14. [Abstract] [Full Text] [PDF]

This article has been cited by other articles:

				A. N. DeMaria, J. J. Bax, O. Ben-Yehuda, G. K. Feld, B. H. Greenberg, J. Hall, M. Hlatky, W. Y. W. Lew, J. A. C. Lima, A. S. Maisel, et al. Highlights of the Year in JACC 2010 J. Am. Coll. Cardiol., January 25, 2011; 57(4): 480 - 514. [Full Text] [PDF]

				Adherence to Cardiovascular Performance Measures in Outpatients Journal Watch Cardiology, July 28, 2010; 2010(728): 1 - 1. [Full Text]

This Article Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Rao, S. V. Search for Related Content PubMed PubMed Citation Articles by Rao, S. V. Related Collections Related Articles