Archive for the ‘Evidence-based medicine’ Category

The art of deep extubation

Fair warning — this post is likely to be of interest only to professionals who administer anesthesia or may have to deal with laryngospasm in emergency situations.

There are two schools of thought about how to extubate patients at the conclusion of general anesthesia:

Allow the patient to wake up with the endotracheal tube in place, gagging on the tube and flailing like a fish on a line, while someone behind the patient’s head bleats, “Open your eyes!  Take a deep breath!”

Or:

Remove the endotracheal tube while the patient is still sleeping peacefully, which results in the smooth emergence from anesthesia like waking from a nap.

It will not require much subtlety of perception to guess that I prefer option 2. It is quiet, elegant, and people who’ve seen it done properly often remark that they would prefer to wake from anesthesia that way, given the choice.

There is art and logic to it, which I had the pleasure of learning from British anesthesiologists at the Yale University School of Medicine years ago.

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In the interests of full disclosure, I acknowledge with delight that I have a non-time limited board certificate from the American Board of Anesthesiology (ABA), issued before the year 2000. I can just say “no” to recertification.

The more I learn about the American Board of Medical Specialties (ABMS) and its highly paid board members, the more disillusioned I’ve become. It’s easy to see why so many physicians today have concluded that ABMS Maintenance of Certification (MOC) is a program designed to perpetuate the existence of boards and maximize their income, at the expense primarily of younger physicians.

Lifelong continuing education is an obligation that we accepted when we became physicians, recognizing that we owe it to ourselves and our patients. That is not at issue here. We have an implicit duty to read the literature, keep up with new developments, and update our technical skills.

The real danger of MOC is this:  It is rapidly evolving into a compulsory badge that you might soon need to wear if you want to renew your medical license, maintain hospital privileges, and even keep your status as a participating physician in insurance networks. If physicians don’t act now to prevent this evolution from going further, as a profession we will be caught in a costly, career-long MOC trap. The only other choice will be to leave the practice of medicine altogether, as many already are doing.

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A better pathway to acute care

When patients need acute interventional care, coordinating the transitions away from and back to primary care is a challenge. The common pathway for these patients, no matter what their diagnosis, is an encounter with anesthesiology. But it often happens too late in the process. If we’re involved earlier, physician anesthesiologists can help reduce procedure risk, control costs, and improve the long-term health of this high-risk, high-spend population.                    

The numbers haven’t changed significantly in several years—only five percent of the U.S. population consumes a full 50 percent of annual health care spending, and just one percent is responsible for nearly 23 percent of spending.

Within the top 10 percent of high spenders, most (nearly 80 percent) are age 45 or older. About 42 percent are persistent high consumers year after year, while the majority requires high spending only on an occasional basis. These episodes of high health care consumption often involve surgery or other invasive procedures in the older patient population.

The experience of undergoing surgery inevitably disrupts a patient’s normal routine of care, even if the surgery is a common elective procedure such as a total joint replacement. Too often, the primary care physician may be unaware that the patient has actually undergone surgery.

Even if the patient’s primary physicians are informed of the plan for elective surgery, they may be left out of the loop regarding discharge planning, the need for post-acute care and rehabilitation, and any changes made to the patient’s medication and diet regimen. Lapses in care and deterioration of chronic medical conditions may result, with the frail, older patient population clearly at highest risk.

Why we should rethink current practices

Within every community population, a subset of patients will be in need of procedural care at any point in time. This care may involve an operation. Or it may involve a substantial, invasive procedure for diagnosis or treatment, such as ablation of cardiac arrhythmia, ERCP (endoscopic retrograde cholangiopancreatography), or insertion of an endovascular stent.

The common pathway for this entire population subset, regardless of the diagnosis or any other factors, is an encounter with anesthesiology before, during, and after the procedure. Today, that encounter often begins way too late in the process.

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The best way to avoid being sued for malpractice is to make certain that all your patients are happy and all their outcomes are good.

Reality is seldom so rosy. Patients aren’t necessarily happy even when their clinical outcomes are as good as they can get. In the event of an undesired outcome, an unhappy patient may easily become a litigious one. A 2011 study in the New England Journal of Medicine estimated that 36 percent of physicians in low-risk specialties such as pediatrics, and 88 percent of physicians in high-risk surgical specialties, would face a malpractice claim by the age of 45. Those percentages climb to 75 percent of physicians in low-risk specialties and 99 percent of physicians in high-risk specialties by the age of 65.

Flaws in clinical practice guidelines

Can clinical practice guidelines protect us? We are all beset by the proliferating standards and guidelines of evidence-based medicine. It’s comforting to think that a court may consider adherence to a legitimate clinical practice guideline (CPG) as evidence of reasonable prudence and acceptable practice. At the same time, physicians know that guidelines are imperfect. Many guidelines are debated and revised over time, some are discontinued when they are found to do more harm than good, and some have been found to be contaminated by conflicts of interest.

Some examples:

>  How long should dual anti-platelet therapy be continued after drug-eluting stent placement? Guidelines currently advise dual antiplatelet therapy for six months to a year after stent placement, and aspirin for life. More recently, the Dual Antiplatelet Therapy (DAPT) study suggests that some patients may benefit from extending dual antiplatelet therapy beyond one year in terms of protection against myocardial infarction, but this benefit is accompanied by increased bleeding risk and a possible increase in all-cause mortality. Physicians are advised to “balance risk factors”.

>  Starting in 2001, there was a push toward much tighter control of blood glucose levels in ICU patients. Tight glucose control after cardiac surgery became a quality measure tracked by the Surgical Care Improvement Project (SCIP) and the Joint Commission. The only evidence basis for tight control was a single-center study that associated intensive insulin therapy with improved outcomes including fewer infections, less ventilator time, and a lower incidence of acute renal failure. But the results couldn’t be replicated. In a landmark multicenter report published in 2009, patients receiving intensive insulin therapy with glucose levels kept between 81 and 108 were shown to have more hypoglycemia, higher mortality, and no difference in morbidity or length of stay. Intensive insulin therapy promptly fell out of favor.

>  Many hospitals in the last several years abruptly switched from povidone-iodine antiseptic solution to chlorhexidine-alcohol (ChloraPrep®) for skin preparation before surgery. They did so on the basis of a 2010 study that claimed substantial benefit for ChloraPrep in reducing the risk of surgical site infection (SSI). But in 2014 CareFusion Corp., the manufacturer of ChloraPrep, agreed to pay the government $40 million to resolve Department of Justice (DOJ) allegations that the company paid kickbacks to boost sales of ChloraPrep, and promoted it for uses that aren’t FDA-approved. The DOJ complaint said the company paid $11.6 million in kickbacks to Dr. Charles Denham, who served at the time as co-chair of the Safe Practices Committee at the National Quality Forum and the chair of Leapfrog’s Safe Practices Committee. He championed the use of ChloraPrep without disclosing his relationship with CareFusion. Subsequent studies have not demonstrated the superiority of any commonly used skin preparation agent in reducing the risk of SSI.

Though the evidence may be flawed, evidence-based medicine has shown an alarming tendency to evolve from guidelines into inflexible rules, especially if payment is linked to them. Physicians may come under pressure from regulators and hospital administrators to apply these rules mechanically, with inadequate attention to context or to a patient’s other health issues. As an excellent article in the British Medical Journal last year pointed out dryly, “The patient with a single condition that maps unproblematically to a single evidence-based guideline is becoming a rarity.” A guideline for the management of one risk factor or disease “may cause or exacerbate another—most commonly through the perils of polypharmacy in the older patient.”

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The Dark Side of Quality

Nobody stands up to argue against quality and value in healthcare. You might as well argue against motherhood, or puppies. Yet many physicians are inherently skeptical of definitions of “quality” that are imposed from above, whether by outside evaluators like The Joint Commission, or (worse) by the government.

There’s good reason for skepticism. Some of the “evidence” behind “evidence-based medicine” has turned out to be flawed, tainted by financial conflict of interest, or outright fraudulent. Any experienced physician knows that there are fads in healthcare just as there are in fashion, and today’s evidence-based medicine may be tomorrow’s malpractice. Let’s take a closer look at what’s really going on in the world of quality metrics, and why it matters if payments to you and your hospital are increasingly linked to how you score.

Surgical Site Infections

The financial toll of surgical site infections (SSIs) is huge, estimated in the U.S. at more than $10 billion a year.(1)  A recent retrospective review from the Veterans Affairs Surgical Quality Improvement Program showed that the majority of SSIs are diagnosed only after hospital discharge, and that 57% will require hospital readmission within 30 days.(2)  The Centers for Medicare and Medicaid Services (CMS) stopped paying for care related to SSIs in 2008 by designating them as “never events”, or non-reimbursable serious hospital-acquired conditions. Now SSIs are part of a long list of hospital-acquired conditions that can result in reduced CMS payments to hospitals, and will bring further reduction in payments over the next several years with the implementation of “value-based purchasing”. More than 1400 hospitals will see their Medicare payments cut by as much as 1.25% this year–a margin that could spell financial disaster for hospitals already struggling.(3)

You may already be among the more than 50% of anesthesiologists who have been reporting performance metrics to the Physician Quality Reporting System (PQRS), which is administered by CMS. When the system started in 2007, CMS offered a bonus payment of 1.5% for successful participation, but that soon shrank to 0.5% and will be discontinued after 2014. Starting in 2015, CMS will impose a 1.5% payment reduction for physicians who do not participate in PQRS, and will push the pay cut to 2% in 2016.

If you participate in PQRS reporting, you know that two of the measures that anesthesiologists report are directly aimed at SSI prevention: perioperative temperature management, and antibiotic timing. PQRS measure #193 specifies that the patient must receive “active warming” or have a temperature above 36C recorded within 30 minutes before or 15 minutes after anesthesia end time. Measure #30 specifies that prophylactic parenteral antibiotics must be administered within one hour before skin incision. Compliance with these two measures isn’t hard to achieve, though no one seems to question the cost to the American healthcare system of all those forced-air warming blankets and machines, or ask why giving antibiotics 61 minutes instead of 59 minutes before skin incision is an automatic “fail”.

But have CMS threats and PQRS compliance done any good? A just-published editorial in Anesthesiology concluded: “Despite early efficacy literature establishing the value of specific antibiotic timing and active warming, repeated large database analyses have not observed robust effectiveness across hundreds of hospitals.”(4)   Simply put, as many of us have noticed in our own hospitals, SSI rates have remained about the same.

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