JACC: Will imperfect guidelines spawn 'cookbook' medicine?

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The enthusiastic reliance on "less-than-perfect" guidelines to create performance measures by which payors reimburse and facilities promote for competitive advantage must be tempered, according to a commentary in the in the Dec. 14/21 Journal of the American College of Cardiology.

Jalal K. Ghali, MD, from the Detroit Medical Center Cardiovascular Institute, and colleagues examined the evidence base for heart failure (HF) guidelines and defined their limitations.

They found a disproportionate amount (54.3 percent) of recommendations in the American College of Cardiology/American Heart Association (ACC/AHA) clinical practice guidelines to be level of evidence C (expert opinion and observational studies), compared with level A (26.4 percent) and B (19.4 percent).

Similarly, the 2009 focused update of the ACC/AHA guidelines for the diagnosis and management of patients with HF contains 157 discrete recommendations, of which only 35 are supported by level of evidence A, while 91 are based primarily on expert consensus opinion.

Ghali and colleagues noted that level A recommendations are based on randomized controlled trials, which are subject to inherent limitations including selection bias under-representing the elderly, women and minorities.

The investigators pointed out two separate meta-analyses suggesting that angiotensin-converting enzyme inhibitors have no discernible effect on mortality and that implantable cardioverter-defibrillators provided no mortality benefit in women.

"Despite these studies, current guidelines rarely distinguish use of these therapies on the basis of age, sex or concomitant conditions," they wrote.

While recognizing the fundamental importance of guidelines, Ghali et al said they hope "that publication of this viewpoint will help temper enthusiasm for overzealous conversion of guidelines into performance measures, thereby restoring the vital role of physician judgment and insight into patient management."

In an accompanying response, Frederick A. Masoudi, MD, the chair of the ACC/AHA Task Force on Performance Measures, and colleagues who include the chair of the ACC/AHA Task Force on Practice Guidelines, as well as the incoming chairs of both task forces, said that practice guidelines are "vetted through an exhaustive process of peer review."

Regarding level C evidence being informed by expert consensus, Masoudi et al said, "It is precisely when evidence is lacking or conflicting that clinicians frequently need and request guidance from experts."

While randomized controlled trials may not be ideal, their limitations are taken into account when developing guidelines. Therefore, the task force "appropriately does not recommend differential therapy for women or the elderly simply on the basis of hypothesis-generating subgroup analyses from randomized controlled trials," they wrote.

They also reiterate that the preamble to every guideline states that they are to be used as general guides and that patient care decisions are "ultimately to be made by the treating clinician in view of all of the circumstances presented by a specific patient."

Yet, Ghali et al noted that guidelines have "quickly assumed a central role in healthcare delivery in the U.S." and have become the "foundation on which performance measures are built and, therefore, a major player in assessing the quality of care provided by individuals and institutions, the ramifications of which involve reputation, reimbursement and litigation."

They continued, "We are concerned, however, that in our enthusiasm for collectively endorsing these guidelines, we are marginalizing the importance of physician judgment and inadvertently risking the conversion of guidelines into 'cookbooks.'"

Regarding performance measures, Masoudi et al responded that guideline recommendations define "candidates" for performance measurement, but they must also pass through a stringent methodology that makes them valid, reliable, actionable and measurable.

In addition, the ACC/AHA Task Force on Performance Measures has supported the use of clinical exclusions "in all process measures as a means of avoiding the potentially hazardous overuse of therapies in patients with contraindications."

Masoudi and colleagues concluded by noting that thought leaders are currently evaluating changes to the guideline process including a specific evidence scoring system, the addition of Bayesian analysis and shorter formats.