Evidence-based guidelines today, malpractice tomorrow

We hold these truths to be self-evident:

A hospital administrator with a clipboard is in search of a physician who isn’t following “evidence-based guidelines.”

There are fads in medicine just as there are in fashion — today’s ”evidence-based guidelines” may be tomorrow’s malpractice.

Did your hospital, like so many, abruptly switch from povidone-iodine antiseptic solution to ChloraPrep® for cleaning a patient’s skin before surgery?  If so, I’m sure the staff was told that ChloraPrep would be more effective and cheaper.  No doubt, they were also warned of the extra precautions that must be taken with ChloraPrep to prevent operating room fires, since ChloraPrep contains highly flammable 70% isopropyl alcohol in addition to chlorhexidine.  Even the fire risk apparently wasn’t enough to make hospitals think twice before switching antiseptics.

You (and your hospital’s staff) may not have heard this news. The US Department of Justice (DOJ) announced last month that CareFusion Corp. would pay the government a $40.1 million settlement to resolve allegations that the company violated the False Claims Act by paying kickbacks to boost sales of ChloraPrep and promoting it for uses that aren’t FDA-approved.

Who received kickbacks?  According to the DOJ’s press release, the complaint alleged that “CareFusion paid $11.6 million in kickbacks to Dr. Charles Denham while Denham served as the co-chair of the Safe Practices Committee at the National Quality Forum, a non-profit organization that reviews, endorses, and recommends standardized health care performance measures and practices.”  Another physician with close ties to CareFusion, Dr. Rabih Darouiche, was the lead investigator on a 2010 NEJM article which concluded (not surprisingly) that Chloraprep was “significantly more protective” than povidone-iodine against surgical site infections.

The Leapfrog Group, launched by the Business Roundtable in 2000, claims that its hospital survey is “the gold standard for comparing hospitals’ performance on the national standards of safety, quality, and efficiency.”  On January 30, Leapfrog announced that it accepted the resignation of Dr. Denham, who had served as chair of Leapfrog’s Safe Practices Committee since 2006, amid concerns that Dr. Denham had failed to reveal his “potentially compromising relationship with CareFusion.” At the same time, Leapfrog said it would undertake “a thorough scientific review of its full slate of endorsed safe practices.”

Are you still feeling good about evidenced-based guidelines?

Then you haven’t looked closely enough at another quality measure your hospital may track:  the use of beta-blockers, a type of blood pressure medicine, around the time that patients undergo surgery.  The Surgical Care Improvement Project (SCIP) has defined beta-blocker use as a “core measure” of hospital quality, stating that a patient who has been taking a beta-blocker prior to arrival for surgery must receive a beta-blocker while in the hospital.  The medication must be taken, SCIP says, either the day before or the day of surgery, and on either postoperative day 1 or 2.

Is there a controlled study that demonstrates conclusively that the SCIP beta-blocker measure makes surgical patients healthier?  Or that they recover better from surgery?  No, there isn’t.  Does the SCIP measure track whether the patient’s blood pressure or heart rate are maintained within a normal range?  No, it doesn’t.  All it says is that the patient should receive an unspecified dose of one of a number of drugs in the beta-blocker class.  A physician can be “compliant” with the SCIP measure by prescribing only a tiny dose of esmolol, a beta-blocker whose duration of effect can be measured in seconds.  You don’t have to be a cardiologist to figure out that this is ridiculous.

What’s worse is that aggressive beta-blocker use around the time of surgery may be hazardous.  A 2013 review and meta-analysis of the medical literature concluded that starting beta-blockers before surgery caused a 27% risk increase in 30-day all-cause mortality.   Beta-blockade reduced the incidence of heart attacks, but increased the incidence of strokes and dangerously low blood pressure.

The authors of the SCIP core measure cite scientific evidence to support their recommendations.  Unfortunately, much of the science has been discredited.  Dr. Don Poldermans, a prolific Dutch researcher, led the DECREASE-IV study referenced by SCIP, which is no longer considered credible. The meta-analysis concluded that in DECREASE-IV, “the key data required to judge outcomes were missing and the adjudication committee was fabricated.”

Larry Husten of Forbes.com has been reporting the damage caused by the Poldermans research misconduct with the overwrought headline:  “Medicine or Mass Murder?  Guideline Based on Discredited Research May Have Caused 800,000 Deaths in Europe Over the Last 5 Years.”  Even if Husten exaggerates, it would be reasonable to suspend the use of the SCIP beta-blocker measure pending further review.  Good control of a patient’s blood pressure and heart rate is a doctor’s version of common sense, and another medication might be better than a beta-blocker for a specific patient’s needs.  First-class chefs don’t base their success on slavish adherence to a cookbook recipe.

Sadly, the federal government has seized on adherence to “evidence-based guidelines” as a way of demonstrating “quality” in health care.  On February 6, key lawmakers unveiled plans to replace the Medicare Sustainable Growth Rate (SGR) formula with a new “Merit-Based Incentive Payment System” for physicians.  This system will include payment bonuses or penalties based on a composite performance score.  Patients as well as physicians should be frightened at the prospect that the government’s version of guidelines for care will forcibly replace physician judgment and experience in caring for patients as individuals.

The good news about the CareFusion settlement is that we may be seeing less of Dr. Denham on the patient safety lecture circuit, playing clips of “Chasing Zero,” the video he produced with his new best friend, actor Dennis Quaid.  The bad news:  hospitals and government agencies hate to admit they’re wrong, whether it’s about ChloraPrep, beta-blockers, or any other bureaucrat’s idea of “quality” in health care.

I have personal experience with standard protocols and core measures as a result of the abdominal surgery I underwent a couple of months ago.  From the hospital’s point of view, I’m sure I met every one of the “targets” they set for me on my “care pathway.”  The only glitch is that I developed a superficial wound infection that took more than two weeks to clear up.  The hospital’s statistics won’t reflect that, because it only became apparent after I left for home. Which skin prep solution was used for my case?  You guessed it–ChloraPrep.  Next time I’ll ask for Betadine.

Karen S. Sibert is an associate professor of anesthesiology, Cedars-Sinai Medical Center.  She blogs at A Penned Point.

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  • NewMexicoRam

    If the AMA were worth its salt, it would tenaciously work at stopping this onslaught of indefensible protocols and guidelines. But, they are consumed with the RUC keeping payments unsympathetically high for specialists.

  • JPedersenB

    Glad to see this being discussed. At present, I do not have much hope that the medical industry will ever get itself straightened out. There are too many conflicts of interest and too much money! Patient care is an after thought…

    • goonerdoc

      As much as it pains me, I agree with most of what you say. However, there are still good doctors out there who put the patient above all else. Please believe me.

      • JPedersenB

        I do believe you but it is hard to find doctors like yourself! The good doctors are getting victimized by the “system,” too….

      • DoubtfulGuest

        :-)

  • ninguem

    Semmelweis did not follow guidelines

    Nor did any 18th century ship surgeon in the Royal Navy that recommended fresh fruits and vegetables to prevent scurvy, which at the time killed more British sailors than battle.

  • Patient Kit

    Speaking of hospital statistics and what they won’t reflect, here’s a line from a job listing this week from a major NYC hospital for an administrative assistant: “Collects and manipulates data to generate various reports for department, hospital and regulatory agencies.” Now, ironically honest as that wording might be, if I was writing that job description, I wouldn’t have used the word “manipulates”. I probably would have spun it and wrote “analyzes data” instead. I realize that manipulation isn’t necessarily a bad thing. But my mind went immediately to a negative connotation and wishing The Wire had one more season to focus on the healthcare system.

  • Bob

    If you check the record you’ll see healthcare False Claims Act cases are not very often even investigated and are left sealed for many years, being the most reported and least acted on. Most of these go back to the FDA which can’t keep anything safe in food or drugs and only get involved in places where they can obtain more money, or friends like: antibiotic effects on hand soap, and animal feed, and now reviewing tens of thousands on OTC products in use for decades! Meanwhile all our drugs and foods are mainly uninspected, coming from China and India.

  • DoubtfulGuest

    Okay, forget this “first” business…if the patient manages to be on your radar at all (as anything other than a potential adversary), you’re doing pretty well. And that’s much better than what I got in the not-too-distant past.

  • SpringTexan

    The headline here needs to be corrected from “evidenced-based” to “evidence-based” –

  • anonymous

    It is impossible for any one individual to keep current with the scientific literature – especially someone in clinical practice. I welcome having others dedicated to synthesizing this new knowledge into evidence-based guidelines. Lets not let a few bad apples spoil the whole bunch. There still exists a very significant research-practice gap, and without evidence-based guidelines, it is known that clinicians tend to provide care according to the standards we learned in training. EBP closes the research-practice gap and I applaud CMS for finding a way to hold clinicians accountable for adhering to these guidelines.