I’m back in D.C. today after a whirlwind couple of days at AHA. It was an exciting trip, reminding me how much I look forward to ACC’s own scientific session in March (not to be missed!).

That said, there’s still one major item left to discuss from AHA’s meeting: the release of ACC Foundation/AHA/Society for Cardiovascular Angiography and Interventions focused updates on the management of patients with ST-elevation myocardial infarction (STEMI) and the management of patients undergoing percutaneous coronary intervention (PCI). It’s only fitting that the document was released during AHA – the update takes into account many of the major trials conducted recently for cardiology and released at AHA and ACC’s meetings. The update makes new recommendations to ensure patients reach lifesaving therapy for STEMI as quickly as possible. 

The update recommends that each community develop a STEMI system for triage and transfer of patients that complies with the standards set forth by Mission Lifeline. The system should include destination protocols to STEMI Receiving Centers and transfer protocols for patients who arrive at STEMI Referral Centers and are primary PCI candidates and/or are fibrinolytic ineligible and/or in cardiogenic shock.

Another significant change recommended in the update is greater acceptance of PCI of the left main coronary artery. The update suggests it may be considered based on favorable anatomic condition and an increased risk of adverse surgical outcomes.

UPDATED: 11/19 with CVN video, as promised.

Electronic health records (EHRs) do not offer complete data to gauge performance, according to a new study in the Agency for Healthcare Research and Quality's Research Activities by Jeffrey Linder, M.D., of Harvard. Linder's research showed that EHRs were often inaccurate in determining the actual cause of a patient visit (688 encounters were billed as pneumonia, but chart reviewers found only 198 actual visits for pneumonia). A large portion of the data in the EHRs was not coded, which makes data extraction for care measures difficult.

This says to me that we’re on the right track with our NCDR registries, with their validated data elements, and with our advice that EHRs be integrated with data registries where possible.

In other registry-related news, the IC3 Program is growing by leaps and bounds! We added a whopping 100,000 patient records this week alone. Amazing. This kind of patient data in our ambulatory registry will really move the needle on quality of care.

Meanwhile, the IMPACT Registry Pilot is on schedule to launch in August for six months to test the usefulness of data elements and the feasibility for data collection. The official launch of the registry is slated for 2010. The IMPACT Registry will be the first national registry to provide data about the demographics, acute management and in-hospital outcomes for a comprehensive selection of patients undergoing diagnostic catheterization or catheter-based interventions for congenital heart disease.

Little is known about the population of patients with congenital heart disease, particularly with respect to the use and outcomes of catheterization and interventional procedures.  To date, most resources have been applied towards increasing the understanding of the anatomy and physiology of congenital heart disease, as well as the natural history of common defects.  National guidelines have been published which provide recommendations for the appropriate use of diagnostic catheterization, interventional catheterization and surgical treatments.  However, because studies performed in congenital heart disease are generally small in number, and because prior registries of congenital heart disease have been limited in scope, there is a paucity of data relating to the use of diagnostic catheterization and catheter-based interventions, and to the morbidity and mortality associated with these procedures.  Current national guidelines were derived primarily from expert opinion, and there is a strong need for data to allow optimization and refinement of the guideline recommendations.

The Brookings Institution recently held a panel discussion of key questions around comparative effectiveness research.  Senate Finance Committee Chair Max Baucus (D-Mont.) and Office of Management and Budget (OMB) Director Peter Orszag offered opening comments. Participants discussed the importance of comparative effectiveness research to overall health care reform for lowering costs, eliminating variation in spending and quality of care, and promoting measurement and benchmarking.

Citing the recent JAMA article underscoring our desire and need to enlarge the evidence base for ACC/AHA guidelines, panelists noted that comparative effectiveness research could help develop more robust guideline evidence in the future.

Meanwhile, ACC’s new policy position on comparative effectiveness and clinical effectiveness research is due to be disseminated and published soon!

*** Image from Flickr (Leo Reynolds). ***

The ACC/AHA Task Force (TF) on Practice Guidelines (GL) convened in Chicago last week to continue its meticulous examination of the process and methodologies for guideline development. This important group, under the leadership of Dr. Alice Jacobs, is committed to rigorous scientific and ethical standards, near-continuous analysis of new studies to keep guidelines current and relevant, and easy accessibility by users. We’ve asked this beleaguered TF to “turbocharge” the GL process to try to keep up with the ever increasing progression of science. (Gird your loins folks, because the National Academy of Sciences says that in the next decade the total body of human science, accumulated from the dawn of humanity to now, will increase by at least 4-7 fold! I know that sounds absurd--unless you’re a Terminator fan who wants to let the machine doctors do their thing for whatever they will be paid then.) 

The point is, how can we keep up? The GLs in the future will be done by benevolent automation I assume. But today, we rely on dedicated volunteers who are already working hard in their day jobs. Asking them to turbocharge is not easy.

Let’s slip back from this transgression from the ‘singularity’ (sentient machine future) to a reality we’re more comfortable with: 54% adherence to GLs and pressure from outsiders (like the IOM) to consider GLs produced by professional societies as perhaps too biased to recognize. We need to be on our toes here. This must remain our AHA-ACC turf.

Our TF rose to the challenge of an uncertain future in my view. We had already decided that those persons with industry conflicts, no matter how dominant in the science of a particular issue, cannot a chair a GL committee, and cannot be panel members without broad disclosure and compelling reason. In the future such individuals may serve only as consultants or testifiers, with no voting privileges, I suspect. We are tightening this up.

In recognition of the critical significance of comparative effectiveness research, members agreed to consider cost and cost-effectiveness whenever relevant and possible in future guidelines. This would not have been considered even 5 years ago. They considered changes to the recommendation language to convey incremental value in comparisons and suggested the addition of health economists and statisticians to the team of contributors. Again, a bold move.  

2009 marks the 25th anniversary of ACC/AHA clinical practice guidelines ... a milestone worthy of celebration! The creation of guidelines has been a joint activity between the ACC and AHA since the 1980s, advancing the missions of both organizations by providing clinical recommendations to improve cardiovascular health. Well-developed guidelines have the potential to enhance the appropriateness of clinical practice, improve the quality of cardiovascular care, lead to better patient outcomes, improve cost-effectiveness, and identify areas of further research needs. Past President Jim Dove, M.D., M.A.C.C., has addressed the challenges we’ve faced over past years, and the future of guidelines as he sees it, in a post on this blog in February.

If you visit ACC Central at booth 2062 (and you really should!) you’ll see our clinical materials all marked with the symbol on the right. We’re giving away free CDs of interactive versions of the guidelines and other tools that will work on your PDA and desktop. We also have the very popular pocket guides: 53 percent of you said that pocket guides are your favorite tool to implement guidelines, in a Lewin Report poll last month.

Today the Journal of the American Medical Association released an article about the importance of funding clinical research, including comparative effectiveness research, to determine the best ways to diagnose and treat heart disease. We at the ACC could not agree more. In fact, one of our staff members is an author of the article, by Drs.Tricoci, Sid Smith and Rob Califf, and our own ACC Joe Allen. The paper sends an important message to the new Administration, Congress and the nation about the need to invest more in science, medical evidence and clinical comparative effectiveness. To turbocharge the guidelines we need a vast amount of new research and evidence! $1.1 billion for comparative effectiveness research and $10 billion for NIH is a start.

Unfortunately, accompanying the article is a disturbing JAMA editorial. The editorial suggests that ACC/American Heart Association clinical practice guidelines lack critical evidence support, despite the fact that they are by far the best evidence at our disposal — and we want more evidence to build more guidelines! Plus these authors suggest guidelines are “cookbooks.” Rather, they offer learning system opportunities to document when and where care should depart from a guideline for a given patient, helping to accumulate data on when and how guidelines need to be updated. No patient perfectly conforms to a guideline, but where is there better science to use to manage care?

The ACC/AHA clinical practice guidelines offer guidance to help health care providers determine the best treatment options for their patients.  These guidelines are developed after careful analysis of the strongest clinical trial evidence available at the time.  In some cases, however, evidence is limited or not available, so some recommendations are based on the consensus agreement of a panel of leading experts in the field of heart disease care.  Once drafted, the guidelines go through substantial peer review and content review by clinicians and scientists at the highest levels of each organization.  The published guidelines represent a product of academic and clinical commentary from a large group of the best minds in the field.

These outstanding guidelines have helped cardiovascular specialists make significant progress in the battle against heart disease. We introduced the first guidelines 25 years ago, and coronary heart disease death rates have fallen by more than 30 percent in the past decade alone. President Doug Weaver was interviewed by WSJ and USA Today, and Board VP Ralph Brindis was interviewed on this by the New York Times.

ACC President Doug Weaver says, “The editorial implies that we should go back 30 years to when a thousand different physicians made a thousand different care plans based on their personal judgments, biases and even lack of knowledge of rigorous scientific findings.” Dr. Weaver is absolutely right. To ignore the ACC/AHA guidelines would introduce even more variation in care than already exists in our health care system.

We DO need more research! But we must continue to apply the best evidence we have diligently NOW until that wonderful day when we have irrefutable evidence for most of what we do.

Please share your thoughts on the article, the editorial and the need for evidence-based guidelines by leaving a comment. Also, check out the recent commentary on guidelines from Immediate-past President Jim Dove, M.D., M.A.C.C.

Going after the $20 billion for health information technology (IT), $1 billion for comparative effectiveness research, $10 billion for NIH clinical research, and $2 – $3 billion for prevention activities in the stimulus bill (ARRA) will be a big-time goal for many organizations. It’s time to get in there and grab some dough. The competition for dollars will be fierce, but we have some very sound ideas about how to spend stimulus funds for quality health care. There is an opportunity for registries to be piloted for quality improvement activities. There is still no reimbursement “business case” proposed, but that too could be piloted. Our academic colleagues need to get ready to go after the NIH dollars as well.

The comparative effectiveness research (CER) piece is probably the most controversial. Frankly we would need $1 B annually for 20 years to really get serious about having the massive amounts of additional evidence we need for turbocharging guidelines, performance measures and appropriate use criteria.

Separating cost effectiveness from clinical effectiveness is key to de-politicizing the CER process. Cost effectiveness is critical, but it needs to be done once an objective clinical effectiveness process is completed around any topic. The ACC strongly supports clinical CER. But, one of the risks here -- as shared this week by Avalere Health is that some observers see CER as a way for the federal government to take complete control over guidelines, performance measures and appropriate use criteria. AHRQ shares openly how they did not succeed well in this, when they did try engaging in guideline development a few years back. It costs them too much to produce what we can do with mostly volunteer FACC and researcher efforts; and they got hung up in dangerous political issues in the Congress when various elements of industry didn’t like their results. Better to have a federal agency like NQF or AHRQ look over the shoulders of the profession to vet our guideline efforts, which are bound to be more trustworthy to physicians, and therefore more widely adopted.

Stay tuned, and be certain ACC will be centrally involved in pushing for the best, most objective, and patient centered evidence. We need more of it -- and it’s a important part of the profession’s accountability -- to lead in making that happen! Importantly, we need to clarify to the confused that guidelines are not rigid cookbooks -- see the post last week from ACC past president Jim Dove.

*** Obama signs ARRA into law. Image from Wikimedia Commons (Pete Souza) ***

This post comes from ACC immediate past President James Dove, M.D., M.A.C.C. Dr. Dove is a clinical professor of medicine, Division of Cardiology, at Southern Illinois University, and a founding partner of Prairie Cardiovascular Consultants, Ltd., a 42-member group of cardiologists. As president, Dr. Dove set in motion ACC's efforts in implement quality in cardiovascular care.

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For 25 years, the American College of Cardiology Foundation and the American Heart Association have produced clinical practice guidelines.  These guidelines carefully review the available evidence, rank the importance and significance of major trials and the voluminous medical literature. The results are lengthy guidelines with a series of recommendations, classified as I, IIa, IIb, and III, depending on the strength of the recommendations.

The documents are a wonderful distillation of the literature and serve as a tremendous resource guide to practitioners.  They are, however, difficult to apply at the bedside.  Numerous attempts have been made by the College to help address that difficulty.  Wall charts, pocket guides and other tools have been produced in an effort to facilitate clinical application.  These processes, while helpful, have failed in the application of the Class I guideline recommendations 100% of the time in every patient in whom the recommendations are appropriate.

Best practices in the future will use computer decision-support tools (CDS) that function well within the clinical workflow and facilitate decision-making as well as providing reminders at the point of care.  These tools can also automatically collect process measures without requiring additional time-consuming chart reviews.  Computer decision-support tools will allow us to apply the guidelines every time to every patient for whom the guideline is appropriate and to document clearly the reasons a specific recommendation is not appropriate for a given patient.

The time is now to adopt and develop these computer decision-support tools to function at the point of care, document quality and facilitate our adherence to best medical practices. 

This is not cookbook medicine – instead, it allows us for the first time to effectively collect data about adherence to guidelines, appropriate deviations from guidelines, and eventual correlation of process measures and the effects of those measures on clinical outcomes.   There is no better way to document the significance of process measures of all classification levels than to do so at the point of care and correlate that information with clinical outcome in thousands of patients.

- By James Dove, M.D., M.A.C.C., ACC immediate past president

* Dr. Dove's post is the fourth in a new monthly series of guest posts by ACC leadership. Check back next month to see which ACC leader is sharing his or her thoughts on health care reform!