Shelley Wood

November 14, 2011

November 14, 2011 (Orlando, Florida) — It was supposed to be a spotlight session announcing key details from long-awaited blood-pressure, cholesterol, and obesity guidelines from the National Heart, Lung, and Blood Institute (NHLBI), but no red carpet was rolled out today. Instead, the NHLBI session here at the American Heart Association 2011 Scientific Sessions offered a glimpse at what questions expert writers are seeking to answer and some explanation for why things are taking so darn long.

The last Adult Treatment Panel Detection, Evaluation, and Treatment of High Blood Cholesterol Guidelines (ATP III), were issued in 2001 with an update in 2004. The Seventh Edition of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) came out in 2003. And the first and only Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adultsguidelines from the NHLBI were issued more than 10 years ago, in 1998. Concerns over just what is holding back the new guidelines and what the impact of those delays may be have been mounting for several years.

Dr Sidney Smith (University of North Carolina, Chapel Hill, NC), who presented an overview of how the guidelines are being developed during today's session, acknowledged that the protracted process has caused some grumbling.

"All of us would have liked to have seen this move faster," he told heartwire . In fact, the aim was to have something more concrete to present at AHA. "We'd hoped to have the recommendations ready here," he said.

Dr Sidney Smith presents a status update from the NHLBI CV guidelines

IOM Recommendations Improving Product, Slowing Process

A key factor in slowing down the guideline process--but one that all of the speakers today seemed to agree would improve their overall quality--was a March 2011 report from the Institute of Medicine (IOM) laying out standards "for developing rigorous, trustworthy clinical-practice guidelines."

Dr Suzanne Oparil (University of Alabama, Birmingham), who presented the update on JNC 8, acknowledged to heartwire at the end of the session, "it's a different process," one that does run the risk of being "hard to keep up to date" as more time passes.

"Undoubtedly the old process was much quicker. But, as you heard, there is all this emphasis on the evidence base and diversity of interests, and this is what the Institute of Medicine recommends."

In the case of JNC 8, she noted, the expert committee has taken its literature review all the way back to 1966; going forward, the guidelines will be continually updated, since this part of the process has been particularly arduous.

"It is unfortunate that the process is taking so long," she agreed. "If there were more resources available to use for the literature searches and whatnot, it would have gone somewhat more rapidly."

Likewise, Dr Neil Stone (Northwestern Memorial Hospital, Chicago, IL), who presented the update on ATP 4, stressed to heartwire that "the [new IOM-recommended] process is designed to eliminate bias from any source, not just related to industry, but also individual passions or research interests. So the process involves various layers of work that just take more time."

He says the ATP panel has been meeting every week for an hour and a half, plus countless additional hours of solo work per week. "If you look at the questions we've asked, we're not simply trying to extrapolate from prior guidelines, we're trying to set a foundation for how we view our evidence and extrapolate recommendations in the future."

Evidence Base and Patient-Specific Needs

In the case of ATP 4, he noted, there is growing debate over lipid-lowering strategies. "Some have argued for a strategy based on the fixed doses that were studied in trials. Others have talked about a strategy of tailoring statin dose to risk, rather than [trying to reach] an LDL-cholesterol goal. "So additional examination of all the evidence in this area was felt warranted by the panel," he said.

The ATP expert group is also trying to simplify the guidelines. "Our whole panel is hopeful that this long wait will be worthwhile, but we certainly don't want to shortchange the process, because at the end what we care about are the guidelines that make it fully evident how we arrived at our recommendations for patient care."

Smith, likewise, agreed that while the wait has been controversial, he doesn't believe it’s a disservice to physicians or patients.

"The important thing is to get it right. If the guidelines that get out there end up maybe treating people who don't need to be treated, that is also a disservice. I think, yes, we're just now getting into the recommendations phase, but this focus on evidence is going to serve physicians and patients very well."

Smith continued: "Let's put it this way. If what people are doing now is correct, and there's no change recommended, then we're fine. If we do come up with very substantial changes, we want to be very careful that they are strongly based in evidence."

"Critical Questions"

For today's session, in lieu of recommendations, chairs from each of the three guidelines gave status reports, listing who had been chosen as expert panel members and showing how many thousands of papers--around 39 000 in total, according to Smith--had been screened, graded, and abstracted.

All three guidelines have now distilled relevant studies into a set of what all of the speakers termed "critical questions" that their expert committees will use as the basis for their recommendations. Dr Ralph Sacco (University of Miami Miller School of Medicine), who chaired today's session, did his best to rouse the audience's interest in this part of the guideline process, calling it the "first-ever look" at the issues on which the recommendations would be based.

"Critical questions": ATP 4, JNC 8, Obesity 2

Guideline

Questions

Notes

ATP 4

1. What evidence supports LDL-C goals for secondary prevention?

2. What evidence supports LDL-C goals for primary prevention?

3. What is the impact of the major cholesterol drugs on efficacy/safety?

Diet and exercise are being addressed in the separate lifestyle working group. Both randomized controlled trials and high-quality meta-analyses considered

JNC 8

1. Does initiating antihypertensive pharmacological therapy at specific BP thresholds improve health outcomes? When should you initiate treatment?

2. Does treatment with an antihypertensive pharmacological therapy to a specified BP goal lead to improvements in health outcomes? How low should you go?

3. Do various antihypertensive drugs or drug classes differ in comparative benefits and harms on specific health outcomes? How do you get there?

The antihypertensive guidelines are only using randomized controlled trial evidence

Obesity 2

1. What are the benefits of weight loss?

2. What are the risks of being overweight?

3. What is the efficacy/effectiveness of different diet strategies?

4. What is the role of comprehensive lifestyle intervention (diet plus physical activity plus behavioral therapy in achieving and maintaining weight loss?

5. What are the benefits and risks of various bariatric surgery procedures?

Guidelines will not tackle pharmaceutical interventions, due to "a lack of sufficient evidence"

All three guidelines will be out "sometime in 2012," speakers said today. Smith is predicting that will be within the first half of the year. A fourth set of guidelines, Cardiovascular Health and Risk Reduction in Children and Adolescents, was ready and released in time for AHA 2012, as covered by heartwire .

And, in case anyone is enjoying the guidelines waiting game, there's more in store: Smith announced today that NHLBI advisory groups have asked for something more.

"They said keep the panels, keep the reports on hypertension, cholesterol, and obesity, but also develop an integrated guideline, because when the patient comes in the door we don't want to pull three reports off the shelf," Smith told his AHA audience.

Once the separate JNC 8, ATP 4, and Obesity 2 documents are over and done with, another group of experts, with Smith as chair, will be trying to collate this information into a single, integrated guideline.

"I hope we can do that within two years," he told heartwire .

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