A bill that would de-fund the U.S. Department of Health and Human Services Agency for Healthcare Research and Quality (AHRQ), an agency ACC has long supported, has passed through the House Labor, Health and Human Services and Education (Labor-HHS) Appropriations Subcommittee.

Although it is thought that the bill will progress no further in the House, it is a startling message, and urges us to emphasize the importance of patient-centered outcomes research and health services research. Earlier this year, the ACC testified before the House Labor-HHS Appropriations Subcommittee about the importance of AHRQ and health services research among other federal programs, and recently the College signed a Friends of AHRQ joint letter to the House urging them to reject the bill that de-funds AHRQ.

As you probably know, AHRQ’s funding goes towards research related to health care costs, quality, and access. These topics are crucial as we navigate health care reform and emphasize quality, value, and outcome in a new and more sustainable health care system. One of the ways the ACC and AHRQ have been working together is through the AHRQ’s National Partnership Network. As mentioned in a previous blog post by AHRQ Director Carolyn Clancy, MD, the College recently joined the AHRQ Effective Health Care Program to provide our members with free research and educational tools. The Agency also provides comparative effectiveness research (CER), which is important since it compares drugs, therapies, medical devices, tests, surgeries, or ways to deliver health care in the search for a more value driven system. Research summaries are available through AHRQ and are designed to help clinicians and patients compare a variety of health care interventions and treatments, and to understand the benefits, harms, and side effects of these various approaches. Members can also participate in the research development process, and there is a plethora of tools available for physicians and their patients on AHRQ’s website.

The new federal fiscal year begins on Oct. 1, 2012, so Congress must act on appropriations by then to continue funding federal agencies. With the election looming, every indication is that Congress will once again resort to enacting a continuing resolution this fall to fund programs into the new year. Regardless, we must continue to educate members of Congress on the importance of federal programs such as these, in order to prevent future bills that defund these programs from passing.

To learn more on the topic, read an article on CardioSource.org.

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The good news in the 2011 National Healthcare Quality Report and National Healthcare Disparities Report released Friday, April 20, by the Agency for Healthcare Research and Quality (AHRQ) is that there have been significant improvements in cardiac care, in areas including reduced hospital admissions for congestive heart failure and fewer hospital deaths due to heart attack.

Unfortunately, the less good news in the reports is that overall improvements in the quality of health care continue to progress at a slow rate – only 2.5 percent a year, and the majority of disparities based on race and ethnicity, socioeconomic status and other factors are either not improving or are heading in the wrong direction.

Working together we can overcome the challenges to future successes and improve the quality rates overall. Chief among the challenges is that health care providers are increasingly being asked to do more – and do it better – all while trying to make sure we guide our patients to the latest credible, evidence-based information and encouraging them to become more engaged with us in their own health and health care.

In our work to improve quality and access to care, AHRQ is building a much-needed resource of comparative clinical information on a variety of priority health conditions, such as cardiovascular disease. The work is being conducted by the Agency’s Effective Health Care Program, the first Federally mandated initiative to support patient-centered outcomes research. As part of this effort, AHRQ is establishing a national network of partners including ACC.

Patient-centered outcomes research, also known as comparative effectiveness research, takes a comprehensive look at the evidence, comparing the effectiveness and risks of various treatment options, and presenting bottom-line results to help you work with patients to answer the question, “What is the best treatment for this individual?”

Data in the quality and disparities reports show strides have been made in answering some of these questions in cardiac care. Along with advances involving congestive heart failure and hospital deaths, racial and ethnic disparities in cardiovascular care were less common than those in other conditions and, in fact, minorities often received better quality care than whites.

Through the Effective Health Care Program, AHRQ conducts systematic reviews of available research to compare the effectiveness, benefits, and potential risks of different treatment options: drugs, medical devices, tests, surgeries, or delivery methods. These evidence-based findings are synthesized into comprehensive reports and translated into plain-language clinician and patient summaries on topics such as effectiveness of self-monitored high blood pressure, combination therapy for high cholesterol, and ACEIs, ARBs, or DRI for high blood pressure. Continuing education credits and slide libraries on cardiovascular patient-centered outcomes research are also available. These resources are designed to encourage and support shared decision making between the patient and clinician, resulting in better care.

As an advocate for evidence-based research and informed decision-making, ACC has joined AHRQ’s national network of partners to share the Agency’s growing inventory of free research reports and tools to help clinicians educate patients about cardiovascular disease, and work with patients to make informed decisions about care. You can view these tools on the AHRQ Effective Health Care Program website, or order free copies of the summary guides, including the consumer guide AHRQ recently cobranded with ACC titled “Measuring Your Blood Pressure at Home: A Review of the Research for Adults” by calling 800–358–9295 and using code C-01.

Together we will increase awareness of patient-centered outcomes research and encourage patients to use this kind of research to help them make the best treatment decisions.

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Please note that statements or opinions expressed herein reflect the views of the contributor, and do not reflect the official views of the ACCF, unless otherwise noted.

This post was authored by Dipti Itchhaporia, MD, FACC, chair elect of the ACC’s Board of Governors.

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According to WomenHeart, heart disease is the leading cause of death of women in the U.S. Nearly five times as many women will die from heart attacks alone this year than will die from breast cancer. Women have a 28 percent increased risk of dying as compared to men to die within the first year after a heart attack. Unfortunately, the vast majority of cardiovascular research has been performed on men and/or data have not been separated out based on gender.  Where men and women have been studied separately, some important differences have been identified.

Yesterday the ACC co-hosted a Gender Data Forum with the Society for Cardiovascular Angiography and Interventions’ (SCAI’s) Women in Interventions, to explore the information and statistics that are available. The forum featured primary investigators from major clinical trials who discussed gender data differences in their trials that specifically looked at anti-platelet and anti-thrombolytic therapies in Acute Coronary Syndrome (ACS). Studies included PLATO, TRITON, CURRENT OASIS, GRAVITAS, HORIZONS/ACUITY, ATLAS ACS, Fondaparinux, Integrellin, Abciximab, CHARISMA and CURE, and FRISC II.

By examining and discussing the results from these studies and commenting on the comparative effectiveness, the goal was to hone in on the differences in these studies that we could further explore and better understand as we think about future research and trials examining differences in gender. A further goal is to increase gender specific data in future studies.

Overall the forum was successful and there were several ideas that resulted from the discussions as we look to impact regulatory agencies, industry, physicians and patients to reduce health disparities.  Our hope is to compile our learnings from the forum into something that can be useful and more widely distributed, so stay tuned for more information. In the meantime look for upcoming ACC educational sessions on women’s health disparities, including the Heart of Women’s Health meeting in January and hot topics at ACC.12 in Chicago.

This morning I went to a meeting on the “Do’s and Don’ts of Comparative Effectiveness Research.” Comparative Effectiveness Research, also called CER, has been the topic of much discussion since it was included in the stimulus package (American Recovery and Reinvestment Act of 2009). CER is a topic that has been discussed extensively on the ACC in Touch Blog, in part because it’s such a hot topic and in part because how it’s structured in the future could have wide-sweeping impacts on the practice of medicine.

Why so? Clearly, understanding the relative benefits and harms of two treatments is beneficial to providing the highest quality of care possible. CER has the potential to provide valuable information on the relative value of competing drugs, devices and treatment strategies, which in turn could improve outcomes, efficiency and satisfaction.

However, where the controversy comes in is how this ties into reimbursement for drugs or treatment options. If Drug A is superior for most patients than Drug B, then there is the potential that Drug B could stop being reimbursed by Medicare, which then may trickle down to private insurers. This isn’t problematic for the large majority of patients who benefit from Drug A – but what about the minority of patients who actual do better on Drug B? Should they have higher drug costs because they’re in the minority?

It’s the tie between money and effectiveness that’s at the root of the issue, and it continues to be a hot topic as evidenced from this morning’s meeting. In addition, the quality of the trials conducted – given their wide-reaching implications – is of utmost importance. The trials need to stand up to the strictest research standards to ensure that the findings are able to reflect what’s actually happening in the population.

The ACC wholeheartedly support CER for the value it will add to our cardiovascular knowledge, but recognizes the potential for it to be used to deny coverage. That’s why in 2009, the ACC released an advocacy position statement on CER, articulating where we stand on the issue. Its main findings:

• The ACC strongly supports CER as a way of having informed decision-making.
• CER priorities should be set by a multi-stakeholder group to ensure that the research agenda reflects the needs of the country. The research agenda should be based the burden of the disease being considered, mainly morbidity and mortality.
• The ACC recognizes that the research on comparative effectiveness is “only the first step in improving the quality, equity and efficiency of medical care,” and stresses that improving quality must be the primary aim of CER.
• CER should be distinct from entities that create coverage and benefit programs, and requires close monitoring to avoid adverse consequences on access, quality or safety.
• The ACC recognizes that CER will require substantial and long-term financial support.

The policy statement concludes: “The ACC believes CER research, when conducted correctly, is a useful tool that assists physicians and other providers in delivering high-quality, equitable and effective health care to patients.”

CER MUST separate cost efficiency from clinical effectiveness. Not only is this necessary to ensure coverage for all patients, it also is necessary to maintain physician and patient trust that CER is untainted scientifically from societal/government pressure to reduce costs.

Below are some related resources if you’re interested in learning more about CER, including a video on shot at one of last year’s Medical Directors Institutes. I’m interested to hear your views on CER in the comments section below.

• ACC 2009 Advocacy Position Statement: Principles for CER
• Guest blog post from former ACC Chapter President John Brush, MD, FACC on how he feel CER should be structured
• All past blog posts on comparative effectiveness

Just what so many people feared: comparative effectiveness research (CER) is really a metaphor for comparative payment and -- (dum-da-dum-dum) -- rationing! But, wait a minute. It doesn’t have to result in rationing... what if it was a rational way to create fair payment?

In other words, if the science for CER was considered reliable, evidence-based, and patient-centered (including having a balance of gender, ethnic, and pediatric patients included, for example), then why not pay for interventions and services with better outcomes, and equivalent pay for different services with comparable outcomes?

In the latest edition of Health Affairs, Steven Pearson and Peter Bach propose a novel approach to re-calibrating Medicare payment. Pearson is president of the Institute for Clinical and Economic Review at Massachusetts General Hospital's Institute for Technology Assessment. Bach is an attending physician at Memorial Sloan-Kettering Cancer Center in New York City and a former adviser to the CMS Administrator.

Pearson and Bach note that the Affordable Care Act (ACA) puts strict limits on the ability of the federal government to draw on CER to determine what can be covered under Medicare. But they believe that using well-performed CER to determine how much to pay for newly covered services could yield billions of dollars in savings without threatening patient choice. This really is worth considering. But note that the new PCORI (Patient Centered Outcomes Research Institute), upon which ACC Trustee Harlan Krumholz sits, is precluded from determining payment methodologies.

Under the three-pronged model set forth by Pearson and Bach, Medicare would pay more for interventions that research had demonstrated provided superior results for patients. By the same token, when two interventions demonstrated comparable clinical effectiveness, Medicare would pay the same amount for both. When a new service or treatment lacked any comparative evidence, Medicare would set a tentative payment while research on the intervention's effectiveness was carried out. After three years, if there was no clear evidence that the new service had a clinical advantage over an alternative intervention, Medicare could reevaluate what it would pay for the service.

For new CV interventions (TAVI, Ablation, cell therapy, etc) coverage with evidence development (CED) using registries could accelerate getting data needed for such CER research! We have the registries.

H2H leader Harlan Krumholz, FACC, recently wrote an op-ed for the Washington Post on the value of negative studies on research. He writes:

Negative studies -- the ones that fail to find that one therapy is superior to another -- usually do not elicit much excitement. Scientific studies with breakthrough results establishing the effectiveness of something new tend to get all the attention, while those that fail to find the hoped-for results are often ignored. ...

Rather than a letdown, the failure to find an advantage in an expensive strategy opens the door to doing less and spending less without worsening patient care -- and in some cases improving it. It's simply the case that many popular medical strategies have little or no rigorous scientific evidence of their effectiveness regarding patient outcomes.

Harlan makes some valid points. While new breakthrough trials are certainly most exciting, clearly, value resides in trials that provide evidence against existing therapies so that we can be ever-improving the quality of care we offer to patients. I think that not only will publishing and paying attention to negative studies help, so will comparative effectiveness research. This research will put popular treatments head-to-head so we can know how they truly compare. If the strategy that “wins” in these trials actually involves less treatment, our health system will be all the better for it (given its current out-of-control cost spiral). However, given the relatively limited funding available for comparative effectiveness research, it will be crucial that the strategy be combined with greater respect, and publication of, negative studies.

Just as we envisioned, our NCDR^® registries are becoming powerful tools for comparative effectivenessresearch (CER). The TRANSLATE-ACS Study, led by the Duke Clinical Research Institute (DCRI) in collaboration with the ACC, is a longitudinal, observational study ofacute coronary syndrome (ACS) that relies on the CathPCI Registry^® for much of its data collection. The overall goals of TRANSLATE-ACS are to examine in-hospital and longitudinal outcomes of ACS patients managed with percutaneous coronary intervention (PCI), and to assess post-discharge care patterns and treatment adherence.  In particular, the study will look at how physicians are making treatment choices among approved antiplatelet therapies; factors influencing adherence to these medications; and real-world effectiveness, safety and costs in a broad-based patient population.

TRANSLATE-ACS intends to enroll approximately 17,000 STEMI and NSTEMI patients treated with PCI and discharged on an ADP-receptor inhibitor (clopidogrel, prasugrel, ticlopidine).  For sites already participating in CathPCI, many of the data elements collected for TRANSLATE-ACS will be automatically imported from the registry. Patients will be followed centrally via telephone up to 15 months after discharge to assess patterns of treatment and even rates.

This study, headed up by John Messenger, MD, FACC, and Tracy Wang, MD, FACC, and Eric Peterson at Duke, MD, MPH, FACC, complements ongoing ACC efforts to expand the role of registries in CER and conduct CER using a continuum of information from the inpatient to outpatient settings.

Recruitment for TRANSLATE-ACS is underway, so if you are interested in participating or would like to get more information about the study, I encourage you to e-mail DCRI at TRANSLATE-ACS@mc.duke.edu. 

Yesterday I spoke at a session on practice management called “Practice Innovation: How to Reduce Costs and Increase Quality.” This session offered a high-level look at the many resources the College has available to help practices deliver high quality care while saving money.

The session had an all-star lineup: former (as of convocation last night) ACC President Fred Bove, M.D., M.A.C.C., and now current president Ralph Brindis, M.D., F.A.C.C., were the session chairs. Ralph gave a talk about the role of registries in a reformed health care system and how registries can help measure success, reduce health care disparities and serve as an important tool in comparative effectiveness research (similar to what I wrote about on Sunday).

ACC SVP of Science and Quality Janet Wright, M.D., F.A.C.C., talked about the various quality programs that ACC runs, such as the highly successful Door-to-Balloon campaign, the newly formed Hospital to Home program and medication adherence initiatives. Co-Chair of the Health IT Committee Jimmy Tcheng, M.D., F.AC.C., talked about health IT and the tools necessary to adapt to delivery system change. My presentation at the session covered ways of reducing variations in CV care through tools like appropriate use criteria.

This session goes to show all the different ways that the ACC offers members to improve quality in different areas. That said, CV practices around the country are struggling under the recent payment cuts put into effect by CMS to make fewer practice dollars go farther. It’s understandable that the thought of participating in a quality program might seem impossible at this point. However, even in economically distressing times, the ACC continues to promote quality programs because quality must be the core of what we as health care professionals do. At some point (hopefully!), practices will have the resources to fully commit and expand their participation in quality programming.

*** Image from morgueFile (jdurham). ***

The ACC has signed on to support a Consumers Union consensus statement that urges the Senate to retain the Patient-Centered Outcomes/Comparative Effectiveness Research (CER) provisions in health care reform. The good news is how broad and basic it is — amazingly, they got good support from health plans on this.

Both chambers of Congress have different view on CER, including whether to follow the "Federal Reserve" model, in which the research is relatively independent of government, or the government approach, housing the research center within AHRQ. Who will sit on the review board is a bit of an issue, too, but both chambers are looking at a good cross-section of the whole health care community, including government, industry, patients, physicians, researchers and similar stakeholders. 

One of the big fears out there — which it seems is being addressed very carefully in all the legislation I've seen (but that doesn't stop naysayers from hyperventilating about it) — is that the government will use CER as a basis for cost-containment and restrictive coverage decisions. Critics are using the recent mammography guidance as an example of rationing through CER. To be clear, the ACC and Consumers Union wholeheartedly support CER that separates cost efficiency from clinical effectiveness.

Our ACC Medical Directors Institute this year focused completely on CER, and we'll continue to delve more deeply into some topics, such as shared decision-making with patients/providers and helping IOM and the Federal Coordinating Council for CER in action plans related to their research priorities.  It will be interesting to watch this unfold!

I talked a little bit earlier this week about comparative effectiveness research (CER) and the role of cost effectiveness in this research. At ACC's Medical Directors' Institute, a variety of views on the topic were given. Tell me what you think below (and check out what others have said in previous posts on the topic).