Posts Tagged ‘Evidence-based medicine’

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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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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Dr. Sandeep Jauhar, a cardiologist, believes with good reason that many physicians have become “like everybody else:  insecure, discontented and anxious about the future.”  In a recent, widely-circulated column in the Wall Street Journal, “Why Doctors Are Sick of Their Profession,” he explains how medicine has become simply a job, not a calling, for many physicians; how their pay has declined, how the majority now say they wouldn’t advise their children to enter the medical profession, and how this malaise can’t be good for patients.

Dr. Jauhar gets it right in many ways, but the solutions he recommends miss their mark completely.

I was 100% in accord with Dr. Jauhar when he argued that “there are many measures of success in medicine:  income, of course, but also creating attachments with patients, making a difference in their lives and providing good care while responsibly managing limited resources.”

The next paragraph, though, I read with astonishment.  Does Dr. Jauhar really believe that publicizing surgeons’ mortality rates or physicians’ readmission rates can be “incentive schemes” that will reduce physician burnout?  Does he seriously think that “giving rewards for patient satisfaction” will put the joy back into practicing medicine?

If so, I’m afraid he doesn’t understand the problem that he set out to solve.

The truth behind “quality” metrics

There is no question that some physicians are inherently more talented, more dedicated, and more skilled than others.  In every hospital, if you speak to staff members privately, they’ll tell you which surgeon to see for a slipped disk, a kidney transplant, or breast cancer.  They’ll tell you which of the anesthesiologists they trust most, and which cardiologist they would recommend to someone with chest pain.  But none of these recommendations are based on simplistic metrics like readmission rates or even mortality rates.  They are based on observations over time of the physicians’ ability, integrity, and conscientiousness–all of which are tough to quantify.

Let’s take, for example, a common operation such as laparoscopic cholecystectomy:  removal of the gallbladder using cameras and instruments inserted through small incisions in the abdomen.  This is a procedure which most general surgeons perform often, with few complications.

When complications occur, there are almost always factors involved other than surgical error.  Patients with diabetes are more likely to develop wound infections, for instance.  Surgery on patients who have had prior abdominal operations may take longer and could cause bleeding or damage to other internal organs because of scar tissue.  Morbid obesity and advanced age are risk factors too.

The surgeon whose mortality rates are higher, or whose patients are more likely to be readmitted to the hospital, may be dealing with a much different patient population from the surgeon with the lowest rates.  An inner-city hospital may admit more patients as emergency cases, in more advanced stages of disease.

It’s difficult for statistics to reflect accurately the dramatic differences among patients that affect surgical outcome.  A noncompliant patient who doesn’t fill prescriptions and follow instructions is more likely to have problems, independent of the experience and skill of the surgeon.  Trying to distinguish among surgeons with “outcomes data” will only result in more surgeons refusing to operate on high-risk patients.

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Here’s a doctor’s health tip for patients that I’ll bet you haven’t heard before.

If you’re a patient who walks into a hospital for an elective procedure of any kind–surgery, or a diagnostic test–and you find out that Joint Commission reviewers are on site, reschedule your procedure and leave. Come back another day, after the reviewers have left.

Why? Because every single person who works there will be paying a lot of attention to Joint Commission reviewers with their clipboards, and scant attention to you.

The Joint Commission has the power to decide whether the hospital deserves reaccreditation. Administrators, doctors, nurses, technicians, clerks, and janitors will be obsessed with the fear that the reviewers will see them doing something that the Joint Commission doesn’t consider a “best practice”, and that they’ll catch hell from their superiors.

For you as a patient, any idea that your clinical care and your medical records are private becomes a delusion when the Joint Commission is on site. Their reviewers are given complete access to all your medical records, and they may even come into the operating room while you’re having surgery without informing you ahead of time or asking your permission.

Perhaps physicians and nurses have an ethical duty to inform patients when the Joint Commission is on site conducting a review. Right now, that doesn’t happen. Does the patient have a right to know?

Unintended consequences

How did any private, nonprofit organization gain this kind of power? Why do American healthcare facilities pay the Joint Commission millions each year for the privilege of a voluntary accreditation review? It’s a classic tale of good intentions, designed to improve healthcare quality, that turned into a quagmire of unintended consequences and heavy-handed regulation.

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Author’s note — Readers may find these related articles of interest:

The Dark Side of Quality

Evidence-based guidelines won’t prevent malpractice claims

Germs and the Pseudoscience of Quality Improvement

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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 medicine” 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 medicine?

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