The release of four prevention guidelines from the American College of Cardiology (ACC) and the American Heart Association (AHA) raised eyebrows, particularly over the use of a new cardiovascular risk calculator and the abandonment of number targets for cholesterol management. ACC President John Gordon Harold, MD, and AHA President Mariell Jessup, MD, discussed the guidelines with Cardiovascular Business. The guidelines were done in collaboration with the National Heart, Lung, and Blood Institute (NHLBI).
Were the societies approached by the NHLBI to take over the guidelines?
Jessup: The NHLBI felt their strengths were around evidence reviews rather than taking evidence and translating that into clinical guidelines. For that reason, they turned to the ACC and the AHA to help produce guidelines from the evidence they had gathered.
Were they a work in progress or did you start from scratch?
Harold: The four prevention guidelines essentially were complete but they had to be mapped to our formal ACC/AHA evidence process in terms of tables. That took a period of time.
Jessup: We also required that these documents undergo yet another peer review. That is necessary because the boards from the ACC and AHA ultimately had to approve them.
Had Dr. Ridker been a reviewer?
Editor’s note: Paul M. Ridker, MD, of Brigham and Women’s Hospital in Boston, raised concerns about the risk calculator after the guidelines were released.
Jessup: The reviewers for the NHLBI were anonymous, meaning the writers did not know who was writing the critiques. He was not one of the reviewers for the ACC or AHA. The writers have assumed he was one of the reviewers but we don’t know that for sure.
Did the authors see the comments before publication?
Harold: The amount of review these documents went through was extraordinary: hundreds of comments and the writing group responded to every single comment put forward. They did not necessarily agree with the comments, but because they were blinded they did not know explicitly who was submitting and how to respond back to that individual. That was the NHLBI process before we received the documents for the AHA/ACC review.
Jessup: Although all of the authors contribute to each article it is often the lead author’s task to respond to each and every comment. If a review comes back and it requires a changing of the wording of a guideline then all the authors need to see it.
You describe this process as transitional. In what way is it transitional?
Jessup: Most guidelines that the ACC and AHA do are an attempt to answer all clinical questions. There aren’t clinical trials addressing every one of those issues [so] writers need to make some recommendations based on consensus.
These guidelines were very different in that they posed a number of critical questions primarily designed by the writing groups. If there were not answers, then they did not have a consensus opinion. There may be some attempt, and this will be up to the new writing committees, to answer some questions that don’t have [trial] evidence by consensus because there is a clinical need.
Harold: We will see these guidelines get reviewed along the more traditional process. Most of the evidence reviewed was up to 2011 so our process going forward will be a more rapid review of the evidence and probably looking at a broader scope of clinical questions and not restricting it to just the critical questions that was done here.
Is that going on right now?
Harold: We have a process for guideline review in development. We are assembling new working groups for all of the guidelines. This is a methodical and deliberate process and we hope to be much more sensitive to new evidence to develop and expand as appropriate and not wait for five years for the next iteration.
Do you see guidelines more as recommendations or a way to change the approach to patient care?
Harold: We are talking about moving to a global assessment of risk. As you think about global risk you have to think about hypertension, diabetes, obesity, lipids and so on. These can’t be taken in isolation. The context going forward is a more deliberate integration of all the guidelines and assessment of global risk. This includes a conversation with patients on how to address their risk factors.
We are expanding the scope to populations who have not been covered very well at this point. In the future we hope to make these guidelines more accessible in a digital format.
Jessup: Are we trying to change clinical practice? Ultimately we are trying to change clinical practice because we think that is what the evidence suggests. But we think it is for the good.
Did you anticipate there might be pushback since this is different?
Jessup: Nobody likes change, even change for the good. We have had big changes in the past that physicians initially had a hard time with. We could have anticipated a lot of concern about moving away from LDL [low-density lipoprotein] targets and toward the management of the person’s total risk. The risk calculator we also anticipated would [elicit] a lot of discussion because there is always another cohort that could be added to the calculation. It was more than we expected but not that much more.
Did you see this as a chance to shake things up and initiate discussions?
Harold: Part of the issue of moving away from targets has to do with the understanding that there have not been clinical trials validating a specific number and it may vary with whether or not [it is] a statin medication or some of the others [classes of drugs].
What this had done is open up a conversation in assessing individual risk. If nothing else, people are talking about cardiovascular risk across the nation. I welcome the conversation. The calculator essentially opens up the dialog and begins the conversation. [It] is not meant to be a knee-jerk response to begin a drug. It is a tool that allows you to begin a conversation on global risk with a patient.
Jessup: While there was a lot of hoopla in the press, in an odd kind of way it did get people talking and reading the guidelines and that in the end is good. We did not write these guidelines to cause controversy. The writers of the guidelines were doing the very best job they could with the evidence out there and realized that this was a paradigm shift and thought it was the right thing to do.
Harold: Part of science is to debate, look at new evidence, modify and have a Socratic dialog and have the ability to evolve over time.
Jessup: When you commit yourself to writing practice guidelines you commit yourself to saying that at some point those will be outdated. Nothing gets implemented by a guideline. People implement care. Guidelines don’t implement care, they guide care.
The four guidelines published in late 2013 are designed to reduce the risk of cardiovascular disease. They focused on cardiovascular risk assessment, cholesterol treatment, obesity and lifestyle management.
Key points include: