Archive for the ‘Evidence-based medicine’ Category

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.

What can be done?

The American Medical Association (AMA), to its credit, passed a resolution this year calling for the “immediate end of any mandatory, recertifying examination by the American Board of Medical Specialties (ABMS) or other certifying organizations as part of the recertification process.” Further, AMA policy states:

Any changes to the MOC process should not result in significantly increased cost or burden to physician participants (such as systems that mandate continuous documentation or require annual milestones).

The MOC program should not be a mandated requirement for state licensure, credentialing, reimbursement, insurance panel participation, medical staff membership, or employment.

Many physicians have rebelled against compulsory MOC and have succeeded in getting the attention of their state legislatures. The state of Oklahoma passed a law in April, 2016, stating that nothing in its laws concerning medical practice shall be construed to make MOC “a condition of licensure, reimbursement, employment, or admitting privileges at a hospital in this state.” Kentucky’s governor signed a more limited measure that forbids making MOC a condition of state licensure. Other states are considering joining Oklahoma as “Right to Care” states.

The California Medical Association (CMA) considered but didn’t pass an anti-MOC resolution at its October meeting. However, there is enthusiasm for pursuing the resolution again in 2017, and it appears to have a strong chance of passing. The title of the resolution is, “Maintenance of Certification should not be used as criteria to assess physician competence”, and it would direct CMA to work with the Medical Board of California to promote legislation prohibiting MOC “as a mandated requirement for physician licensure, credentialing, reimbursement, network participation, or employment.”

NBPAS: An alternative to the ABMS monopoly

If there were unquestioned proof that the MOC process improves patient care and outcomes, then the expense and time would be more justifiable. However, no such data exist. Initial board certification is associated with higher-quality practice, but recertification with MOC programs is not. As Paul Mathew, MD, commented in the November/December 2016 issue of Practical Neurology, “Literature regarding the evidence supporting recertification with MOC programs is weak at best, and most is written by conflicted authors who are executive board members of ABMS boards.”

A good example proving Dr. Mathew’s point is a recent editorial defending MOC in the New England Journal of Medicine (NEJM). The co-authors have close ties to the American Board of Internal Medicine (ABIM) and its foundation, which have been mired in financial scandal. It would be hard to defend a claim to scholarly objectivity.

Dr. Mathew and I are both unpaid, voluntary board members of the National Board of Physicians and Surgeons (NBPAS), an organization founded two years ago by Paul Teirstein, MD, a cardiologist at the Scripps Clinic in La Jolla. Dr. Teirstein’s frustration with ABIM’s expensive MOC requirements led him first to create a web-based petition that rapidly accumulated more than 19,000 physician signatures. He then founded NPBAS as a grass-roots physicians’ organization, offering a cost-effective alternative pathway for board-certified physicians to demonstrate their commitment to continuing medical education (CME) while bypassing the ABMS and MOC.

The challenge, of course, for NBPAS is to achieve recognition by hospitals and insurers, which is a slow process. But progress has been made, as thousands of board-certified physicians (myself included) have earned two-year NBPAS certificates, and thousands more are in the process.

The anti-MOC movement shows no signs of abating. An October, 2016 article in the Mayo Clinic Proceedings concluded that only 24 percent of physicians agreed that MOC activities are relevant to their patients, only 15 percent thought they were worth the time and effort, and 81 percent believed that they were a burden. These results were “pervasive, and not localized to specific sectors or specialties.”

The ABA and MOCA 2.0

To the credit of the American Board of Anesthesiology (ABA), it was one of the first boards to pay attention to the discontent of its diplomates. In May, 2015, it convened a two-day summit to consider redesign of its Maintenance of Certification in Anesthesiology Program (MOCA), and concluded that its ten-year “high-stakes MOC exam is not the most effective way to help its board-certified physicians learn and retain medical knowledge.” The ABA decided to embrace “multiple learning techniques”, and introduced the “MOCA Minute” program, where physicians must answer 30 online questions each calendar quarter or 120 questions annually. This new approach has not brought with it any decrease in cost to participants.

I might be tempted to enroll in the “MOCA Minute” program if I didn’t think that it would be equivalent to stepping in quicksand, and that extrication would be impossible.

After watching residents doing practice multiple-choice questions for years, I’ve reached the conclusion that their time would be better spent reading a good basic anesthesiology textbook and review articles in major journals. The inherent problem with all the multiple-choice questions is that the resident ends up reading three or four wrong answers for every correct one. No wonder they become confused. They would be better off reading only correct information.

I have a fundamental objection also to the ABMS “Six Core Competencies” as the bedrock of the MOC program. Some of them – practice-based learning, patient care, procedural skills, medical knowledge – are fine. But the last two are another matter:

“Interpersonal and Communication Skills: Demonstrate skills that result in effective information exchange and teaming with patients, their families and professional associates (e.g. fostering a therapeutic relationship that is ethically sound, uses effective listening skills with non-verbal and verbal communication; working as both a team member and at times as a leader).

Professionalism: Demonstrate a commitment to carrying out professional responsibilities, adherence to ethical principles and sensitivity to diverse patient populations.”

These are qualities that we all needed to learn and incorporate into our daily practice long before we were board-certified. If you didn’t have an inherent sense of ethical conduct and personal responsibility before you left elementary school, nothing the ABA does is going to change you. If you can’t communicate, a multiple-choice test won’t help. These topics are not properly the business of continuing medical education.

If MOCA is truly valuable, then the ABA should have enough confidence in its product not to make it mandatory. It should compete in the CME marketplace with meetings, journals, online materials, and every other CME product. Board-certified physicians should be able to choose among all these to demonstrate “lifelong learning” and renew their time-limited certification.

It’s time to make it clear to the ABMS that we’re not its indentured servants. The time to do that is now, before it gains any more ground in making our right to work dependent on surrender to MOC.

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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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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