Archive for the ‘Practice Guidelines’ Category

Today’s noteworthy definitions, not new but often ignored:

1. Unintended consequences: The principle stating that an intervention in a complex system tends to create unanticipated and often undesirable outcomes.

2. Good intentions: The paving stones of the road to hell.

In anesthesiology, these precepts should be kept firmly in mind in our attempts to improve “quality”. Anyone who speaks out against measures that are taken under the banner of improving “quality of care” or “patient safety” risks coming across as reckless, heartless, or both. Yet the pursuit of “quality” in healthcare has a track record of implementing changes and policies that haven’t been subjected to any rigorous scientific study, in effect “prioritizing action over evidence.”

Quantitative neuromuscular monitoring

In anesthesiology, we love our gadgets. We especially like gadgets that generate numerical values we can track. It’s no wonder that quantitative nerve stimulators measuring thumb movement via acceleromyography are gaining in popularity. They give us a ratio of neuromuscular recovery that we can document and trumpet as evidence of high-quality care, blessed by the Anesthesia Patient Safety Foundation (APSF) in its most recent recommendations for patient monitoring.

A recent review article in Anesthesiology concluded that “the use of quantitative monitoring may reduce the risk of hypoxemic events and episodes of airway obstruction in the PACU, decrease the need for postoperative reintubation, and attenuate the incidence of postoperative pulmonary complications.”

Note the use of hedging verbs such as “may” and “attenuate”. The authors, Drs. Murphy and Brull, are not claiming that the use of quantitative nerve stimulators should be considered an absolute standard of care or a guarantee of improved outcomes. That’s because they are scientists and understand the hazards of confusing association with causation.

From the trenches of clinical care, is quantitative monitoring turning out to be an unmixed blessing? Hardly, especially if your clinical practice involves trainees. The problem isn’t the technology. The problem is with failure to understand the limits of the technology, and the consequences that arise from uncritical interpretation of the data that the monitor generates.

The electronic health record now badgers us to document quantitative neuromuscular monitoring, regardless of whether the arms are tucked or tightly secured. If the thumb can’t move, the monitor won’t be reliable. A resident may assume the patient is adequately relaxed even if it isn’t true, failing to appreciate subtle signs of return of neuromuscular function such as an increase in peak inspiratory pressure or a change in the end-tidal CO2 waveform. This works until the patient actively bucks on the tube. Our surgical colleagues may be justifiably irritated if they have already remarked on inadequate relaxation only to be told that the patient has no twitches and therefore must be paralyzed.

Conversely, when the monitor demonstrates barely one twitch, the resident may decide to give more muscle relaxant when it isn’t clinically necessary or even appropriate. This in turn may lead to the patient’s being profoundly paralyzed at the end of the case. If the patient received a drug that can be reversed with sugammadex, there may be no problem. However, on one recent morning I took over from the night call team the care of a patient who required a full gram – 1000 mg – of sugammadex to reach full recovery. What was the need to give 100 mg of rocuronium during a renal transplant?

What we’re seeing here are unintended consequences and a steep slide toward mediocrity in the management of muscle relaxation. In the interest of avoiding a citation from the quality-improvement committee for inadequate reversal, residents are steered away from using cis-atracurium, even in cases of complete renal failure, and are getting little experience in the use of neostigmine.

If a patient moves or attempts to breathe over the ventilator, the solution is more rocuronium – not appropriate deepening of anesthesia, improvement of ventilatory parameters, or correction of acid-base status. As TIVA – total intravenous anesthesia – increases in popularity (for reasons unclear to me), the dependence on profound muscle relaxation increases proportionately.

What will happen one day if we have a shortage of rocuronium or sugammadex? Our PACUs will be full of patients on ventilators. In today’s era of supply-chain misadventures, drug shortages are not a merely theoretical concern.

Adverse event reporting

 It’s a good thing – isn’t it? — that errors are now considered system problems, not individual failings. The idea is that we shouldn’t hesitate to report adverse events as these will be reviewed with an eye to correcting system problems, not accusing people. (I’m not so sure that argument is watertight now that a nurse has been convicted of negligent homicide for a medication error.)

Yet there is no question that behavior alters when it is observed and reported on (often referred to as the “Hawthorne effect,” so named after Western Electric’s Hawthorne manufacturing plant where pioneering productivity studies were done in the 1920’s). If the consequences of behavior must be reported, then the behavior will never be quite the same as it might have been without oversight.

Let’s take the example of esophageal intubation. If unrecognized it may be catastrophic, but when immediately recognized we used to think of it as something that simply happened from time to time, especially when working with trainees. Even in the hands of an experienced anesthesiologist, an occasional esophageal intubation can happen if the view during laryngoscopy isn’t ideal or the tube bumps against the arytenoid cartilages. Pull out the tube and reintubate – no harm, no foul.

If you know that you have an obligation to report for quality surveillance every event of esophageal intubation, are you going to allow the medical student to intubate without a video laryngoscope?  Are you going to be less likely to allow a resident to make a second attempt if the first one wasn’t successful? Are you going to bother to document it if you did it yourself and you corrected it right away? Will data on the incidence of esophageal intubation ever be reliable? Probably not.

In my own practice, I’ve noticed that I’ve become less likely to put in central lines than I was even ten years ago. It has become such a time-consuming production. The potential need to report even a minor or insignificant complication seems like more aggravation than it’s worth. Is this a change that’s in patients’ best interest? Maybe, in the sense that I can get some comparable information, maybe even better information, from a minimally invasive monitoring system like the FloTrac®. But it isn’t a change that was made intentionally, after thoughtful study. It’s a behavioral change due to external forces, not an improvement to point to with pride.

Our fault or not?

Anyone who has worked with me or has read articles I’ve written on deep extubation knows that I’m a proponent of extubating deep whenever it’s appropriate, which in my hands is often. If I didn’t intubate the patient awake or use a rapid-sequence induction due to aspiration risk, there must be a compelling reason for me not to do a deep extubation. Residents are eager to learn how to use this technique safely, and they have often asked me why it isn’t used more frequently, at least by Americans.

Though I can’t speak for other anesthesiologists, I suspect that the rationale for awake extubation may come down to fear of criticism and blame more than any scientific evidence of improved quality or safety.

Potential sequelae of deep extubation are clearly anesthesia-related events that would be ours to own and to manage:

Inspiratory stridor and/or laryngospasm

Upper airway obstruction

Aspiration

Potential sequelae of tumultuous awake extubation, on the other hand, aren’t viewed as direct anesthesia complications though they may be precipitated by anesthesia (mis)management:

Dehiscence of an abdominal wound due to coughing

Neck hematoma after carotid or thyroid surgery

Distressing recall of emergence and extubation

Disruption of free-flap anastomosis

Injury or threat of injury to nursing staff who are attempting to restrain a patient during emergence.

All of these have happened to my personal knowledge and weren’t considered anesthesia-related adverse events. It is only human nature to avoid blame and take the path of least resistance, which too often is poorly controlled awake extubation.

The quest for quality

The quest to improve quality is a worthy one. Anesthesiology has an enviable record of safety and of continuous improvement due to the efforts of so many anesthesiologists over many years. But we should never lose sight of the potential for unintended consequences, as explained in the classic NEJM article by Auerbach and colleagues, “The Tension between Needing to Improve Care and Knowing How to Do It.”

Another excellent read is Greenhalgh’s analysis in the British Journal of Medicine, “Evidence based medicine:  a movement in crisis?” She and her colleagues point out that inflexible rules and technology-driven prompts may produce care that is management-driven rather than in the best interests of the patient, and that evidence-based guidelines often map poorly to complex multimorbidity. Jureidini and McHenry go even further in their very recent 2022 BMJ editorial, “The illusion of evidence based medicine,” stating that “evidence based medicine has been corrupted by corporate interests, failed regulation, and commercialisation of academia.”

Too often, the reporting of one or two complications, even if minor, is considered “evidence” that warrants a new policy or protocol as a recipe to prevent reoccurrence. But every misjudgment should not be treated as a critical error requiring systemic intervention.

Especially in large academic institutions, we should beware of the mindset that “the way we do it” is “the standard of care”. This leads only to mindless conformity, and to tolerance of mediocrity if it is consistent with compliance. Isn’t it obvious that this attitude is contributing to physicians’ feelings of futility and burnout in their clinical work?

The patient in front of us deserves to have our best judgment and experience brought to bear in making clinical decisions, regardless of any pathway, protocol, or local custom. Isn’t that the care we would want for ourselves? 

(Author’s note:  This article first appeared in the July 2022 issue of the ASA Monitor)

Keep calm and give the Ancef

A true allergic reaction is one of the most terrifying events in medicine. A child or adult who is highly allergic to bee stings or peanuts, for instance, can die within minutes without a life-saving epinephrine injection.

But one of the most commonly reported allergies — to penicillin — often isn’t a true allergy at all. The urgent question that faces physicians every day in emergency rooms and operating rooms is this:  How can we know whether or not the patient is truly allergic to penicillin, and what should we give when antibiotic treatment is indicated?

It’s time for us to stop making these decisions out of fear, and look squarely at the evidence. Withholding the right antibiotic may be exactly the wrong thing to do for our patients. Here’s why.

Can’t we just prescribe a different antibiotic?

When we hear that patients are “PCN-allergic”, we’ve been trained from our first days as medical students to avoid every drug in the penicillin family. We’re also taught to avoid antibiotics called “cephalosporins”, which include common medications like Keflex. This is because penicillin and cephalosporin molecules have some structural features in common, raising the odds that a patient allergic to one may also be allergic to the other.

What does it matter? Can’t physicians just prescribe a different antibiotic?

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The Practical Art of POCUS

The longer you practice a profession, the easier it is not to bother to learn the next new thing. We may think we’re doing just fine without that new drug, or that new piece of expensive equipment. We’ve seen how the new drug sometimes turns out to have more side effects than benefits, and how the equipment may gather dust in the corner because no one really needed it in the first place.

That isn’t going to happen with point-of-care ultrasound, or “POCUS”, I’m willing to bet. As I learned at a weekend conference on POCUS, jointly hosted by the anesthesiology departments at UCLA and Loma Linda University, the practical applications for bedside patient care are multiplying, and the technology is improving all the time. Ultrasound isn’t just for cardiologists and radiologists any more.

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You may have read about the recent tragic deaths of two healthy children – Marvelena Rady, age 3, and Caleb Sears, age 6 – in California dental offices. Unfortunately, they aren’t the first children to die during dental procedures, and unless things change, they probably won’t be the last.

State Senator Jerry Hill has asked the Dental Board of California (DBC) to review California’s present laws and regulations concerning pediatric dental anesthesia, and determine if they’re adequate to assure patient safety. Assemblymember Tony Thurmond has sponsored “Caleb’s Law”, seeking improved informed consent for parents.

On July 28, I had the opportunity to attend a stakeholder’s meeting at the Department of Consumer Affairs in Sacramento, to hear a presentation of the DBC’s report, and to be part of the delegation offering comments on behalf of the California Society of Anesthesiologists (CSA). We hope this is the beginning of some long overdue upgrades to the current regulations.

By long-standing California state law, dentists and oral surgeons are able to provide anesthesia services in their offices even for very young children or children with serious health issues. They may apply for one of four different types of permits for anesthesia:

General anesthesia

Adult oral conscious sedation

Pediatric oral conscious sedation

Parenteral conscious sedation.

But the route of administration – oral or intravenous – isn’t the point, especially for small children, and oral sedation isn’t necessarily safer. Sedation is a continuum, and there is no way of reliably predicting when a patient will fall asleep. Relaxation may turn into deep sedation, and deep sedation into a state of unresponsiveness which is equivalent to general anesthesia. Oral medications have led to deaths in children, sometimes even before the dental procedure has begun or well after it has finished. There’s no logic in California’s lower standards of emergency equipment and monitoring for procedures done under sedation as opposed to under general anesthesia.

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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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