We on the two coasts of the U.S. were thumped last week by what is sure to be the ugliest national election of our life-time. Politicians will perform “autopsies” to examine how/why a great country has chosen a President whose behavior throughout the election was decidedly (probably purposely) un-presidential. Aside from the extraordinary intuitions and showmanship of this modern PT Barnum, there may be interesting and relevant parallels in Medicine.
Like many starry-eyed medical students, I was drawn to critical care because of the high stakes, its physiological underpinnings, and the apparent fact that you could take control of that physiology and make it serve your goals for the patient. On my first MICU rotation in 1997, I was so swept away by critical care that I voluntarily stayed on through the Christmas holiday and signed up for another elective MICU rotation at the end of my 4th year. On the last night of that first rotation, wistful about leaving, I sauntered through the unit a few times thinking how I would miss the smell of the MICU and the distinctive noise of the Puritan Bennett 7200s delivering their [too high] tidal volumes. By then I could even tell you whether the patient’s peak pressures were high (they often were) by the sound the 7200 made after the exhalation valve released. I was hooked, irretrievably. Continue reading “QUASIPOTENT: A TALE OF THREE HYPOTHESES”
Recently, in the bayside village of Niantic on the eastern coast of Connecticut, I dined al fresco with two chief nurses from my old ICU. As the sun set over Long Island Sound, we caught up on families, fallen comrades, and lamented the perturbations of our professions.
The patient in bed 11, 20-something years old, usually leaves AMA (against medical advice). She has gone AMA three times in as many months after being treated, sometimes partially, sometimes completely, for DKA (diabetic ketoacidosis). This time, she has stayed for a complete course of therapy and I am about to go formally discharge her. As I approach the room, I can hear her sobbing and I pause outside the doorway. I had heard from the nurses that, in addition to using methamphetamine, she has been living on the streets. I wonder how anybody can manage type I diabetes while living on the streets. This is not going to be an easy discharge.
Rivaroxaban is an oral factor Xa inhibitor that was recently approved by the FDA as an oral anticoagulation agent. The FDA approved indications for the use of rivaroxaban include anticoagulation and stroke reduction in nonvalvular atrial fibrillation, treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), for reduction in risk of developing DVT and PE, and for prophylaxis against DVT in patients who recently underwent hip or knee replacement. The approval of rivaroxaban was based on two non-inferiority studies, the EINSTEIN-DVT study and the EINSTEIN-PE study, which evaluated the use of oral rivaroxaban against the current standard therapy comprised of enoxaparin bridging to vitamin K antagonist (VKA) in patients with known venous thromboembolism (VTE). Both studies (found here and here) found that rivaroxaban was noninferior to the current therapy for the prevention of symptomatic recurrent VTE or PE without significantly increased rates of bleeding.
When the editors of the Annals of the American Thoracic Society launched the new journal in 2013, they issued a mission statement that the journal was “To publish the highest quality research, commentaries, reviews, and education content of direct interest to practicing adult and pediatric clinicians in pulmonary, critical care, and sleep medicine.”
This statement is near and dear to me, and not just for its use of the Oxford comma. As clinicians, we are looking for data to help us improve the care of those lives entrusted to us. At the same time, we seek content that keeps us engaged in our craft and sharpens our minds, to make us the best practitioners possible. If you’re reading this on the blog, I am likely already preaching to the choir. But were you to print this and hand it to a colleague that reads journal content only, I’d make an argument for social media in the era of widely disseminated and easily accessible peer reviewed publications.
We all enjoy discussing topics in clinical medicine, just as this blog does. Twitter is an opportunity to catch up with a terrific array of clinicians, researchers, policy-makers, pundits, patients, and families. If you’re already on Twitter, I hope you’ll join us at @AnnalsATSEditors. If you’re not on Twitter, I hope you’ll get an account and join the party. Twitter is a chance to stay abreast of the latest published manuscripts, to see what your peers are reading, hear what others are thinking, and, sometimes, have a nice (and civil) exchange of ideas. All in 140 characters. Our Twitter account is dedicated to not only bringing you the latest published Annals content but also to bring you Tweets from other sources that might pique your interest as an Annals reader. And soon, you’ll be engaging Annals authors directly in Twitter chats.
I hope you’ll follow us @AnnalsATSEditors, and that you’ll also Tweet us your thoughts, suggestions, feedback, and tidbits of interest. See you in the Twittersphere!
It’s no coincidence that the AnnalsATSBlog launched with a focus on weaning. I spent most of my academic career studying methods to more rapidly liberate patients in acute respiratory failure from invasive mechanical ventilation.
Over many years in a previous position, I had the privilege of crafting a culture at Bridgeport Hospital in Connecticut that rapidly embraced new developments in the management of acute respiratory failure, including least sedation and daily spontaneous breathing trials (SBTs), sometimes years before confirmatory data arrived.
So by 2008 when the landmark Awakening and Breathing Controlled (ABC) randomized, controlled trial (Lancet 2008; 371) showed a survival benefit for one in every 7 patients, we had deployed the least-sedation/daily SBT approach for more than 5 years on over 4,000 patients. Our simultaneously conducted “real-world study” (Chest 2009; 136) showed that the approach could reduce median duration of invasive ventilation for medical or surgical patients to an average of 2 days. I know of no study demonstrating a shorter duration of mechanical ventilation for critically ill patients.
The ABC “wake up and breathe” approach to weaning from mechanical ventilation is right because it is common sense, consistent with the theme of almost all seminal critical care findings of the past 2 decades: less is best. Get out of the way. Do no harm. Nature has provided for patients to repair themselves if we can help without harming. So why isn’t awaken-and-wean universal practice?
In my opinion the reasons are simple . . . but complex and reflective of human behavior. We’re resistant to change. We’re arrogant and too often certain our way is the best way. We (demonstrably) do not rapidly embrace new practices even when they are of unequivocal benefit to our patients. We are lazy and it takes time at the bedside both for physicians and staff to aggressively administer the recommendations of the ABC trial. And, while it may be the least important and most unconscious motive, there’s sometimes financial benefit in not enacting ABC.
requires denial of the veracity 20 years of accumulated scholarship that supports sedation/daily SBTs. Counterarguments that every patient is unique and not well served by “protocols” is bogus. On the contrary, “wake up and breathe” permits the patient – with his/her unique physiology – to show when they are ready for extubation, if we simply give them the chance.
After 25 years of practice that has spanned university centers, community teaching hospitals, and non-teaching community hospitals, I have been most astonished and disappointed by the degree to which greed, laziness and arrogance subvert patient care. Failure to awaken and wean – in my experience – has been caused by all 3 core vices.
I plan to focus some of my blog posts on the naked emperors in pulmonary and critical care medicine.
For today’s post, I challenge readers to identify another medical intervention that saves 1 in every 7 lives. If you think you have a better way, test it formally and publish the results so that all patients can benefit. But until that time, there is no excuse for not deploying ABC. In an upcoming article in the Journal of Critical Care, I argue more formally that failure is mal- (i.e. bad) practice and offer measures to repair the weaning quality chasm. Third party payers will need to drive this renaissance and will need to spur a more accountable culture.
Too often, we do not advocate forcefully–locally or nationally–for interventions, like the ABC trial wake up and breathe strategy that reduce patient suffering. If money has to drive this change, it’s disappointing, but no more so than millions of needless patient-vent-days and deaths every year. There’s no excuse for it. It’s simple: use short-acting sedatives as needed only; and every day a patient doesn’t need a ventilator for shock, myocardial infarction or oxygenation (i.e. PaO2/FiO2 >120), let them breathe.
You may be surprised and sometimes startled by how well they do.
“When a distinguished but elderly scientist states that something is possible, he is almost certainly right. When he states that something is impossible, he is very probably wrong.” – Clark’s First Law
It is only fair to follow up my provocative post about a “trial of extubation” by chronicling a case or two that didn’t go as I had hoped. Reader comments from the prior post described very low re-intubation rates. As I alluded in that post, decisions regarding extubation represent the classic trade-off between sensitivity and specificity. If your test for “can breathe spontaneously” has high specificity, you will almost never re-intubate a patient. But unless the criteria used have correspondingly high sensitivity, patients who can breathe spontaneously will be left on the vent for an extra day or two. Which you (and your patients) favor, high sensitivity or high specificity (assuming you can’t have both) depends upon the values you ascribe to the various outcomes. Though these are many, it really comes down to this: what do you think is worse (or more fearsome), prolonged mechanical ventilation, or reintubation?
What we fear today we may not seem so fearsome in the future. Surgeons classically struggled with the sensitivity and specificity trade-off in the decision to operate for suspected appendicitis. “If you never have a negative laparotomy, you’re not operating enough” was the heuristic. But this was based on the notion that failure to operate on a true appendicitis would lead to serious untoward outcomes. More recent data suggest that this may not be so, and many of those inflamed appendices could have been treated with antibiotics in lieu of surgery. This is what I’m suggesting with reintubation. I don’t think the Epstein odds ratio (~4) of mortality for reintubation from 1996 applies today, at least not in my practice. Continue reading “Once Bitten, Twice Try: Failed Trials of Extubation”
“The only way of discovering the limits of the possible is to venture a little way past them into the impossible.” –Clark’s Second Law
In the first blog post, Dr. Manthous invited Drs. Ely, Brochard, and Esteban to respond to a simple vignette about a patient undergoing weaning from mechanical ventilation. Each responded with his own variation of a cogent, evidence based, and well-referenced/supported approach. I trained with experts of similar ilk using the same developing evidence base, but my current approach has evolved to be something of a different animal altogether. It could best be described as a “trial of extubation”. This approach recently allowed me to successfully extubate a patient 15 minutes into a trial of spontaneous breathing, not following commands, on CPAP 5, PS 5, FiO2 0.5 with the vital parameters in the image accompanying this post (respiratory rate 38, tidal volume 350, heart rate 129, SpO2 88%, temperature 100.8). I think that any account of the “best” approach to extubation should offer an explanation as to how I can routinely extubate patients similar to this one, who would fail most or all of the conventional prediction tests, with a very high success rate.
A large part of the problem lies in shortcomings of the data upon which conventional prediction tests rely. For example, in the landmark Yang and Tobin report and many reports that followed, sensitivity and specificity were calculated considering physicians’ “failure to extubate” a patient as equivalent to an “extubation failure”. This conflation of two very different endpoints makes estimates of sensitivity and specificity unreliable. Unless every patient with a prediction test is extubated, the sensitivity of a test for successful extubation is going to be an overestimate, as suggested by Epstein in 1995. Furthermore, all studies have exclusion criteria for entry, with the implicit assumption that excluded patients would not be extubatable with the same effect of increasing the apparent sensitivity of the tests.
Even if we had reliable estimates of sensitivity and specificity of prediction tests, the utility calculus has traditionally been skewed towards favoring specificity for extubation success, largely on the basis of a single 20-year old observational study suggesting that patients who fail extubation have a higher odds of mortality. I do not doubt that if patients are allowed to “flail” after it becomes clear that they will not sustain unassisted ventilation, untoward outcomes are likely. However, in my experience and estimation, this concern can be obviated by bedside vigilance by nurses and physicians in the several hours immediately following extubation (with the caveat that a highly skilled airway manager is present or available to reintubate if necessary). Furthermore, this period of observation provides invaluable information about the cause of failure in the event failure ensues. There need be no further guesswork about whether the patient can protect her airway, clear her secretions, maintain her saturations, or handle the work of breathing. With the tube removed, what would otherwise be a prediction about these abilities becomes an observation, a datapoint that can be applied directly to the management plan for any subsequent attempt at extubation should she fail – that is, the true weak link in the system can be pinpointed after extubation.
The specificity-heavy utility calculus, as I have opined before, will fail patients if I am correct that an expeditious reintubation is not harmful, but each additional day spent on the ventilator confers incremental harm. Why don’t I think reintubations are harmful? Because when my patients fail, I am diligent about rapid recognition, I reintubate without observing complications, and often I can extubate successfully the next day, as I did a few months ago in a patient with severe ARDS. She had marginal performance (i.e., she failed all prediction tests) and was extubated, failed, was reintubated, then successfully extubated the next day. (I admit that it was psychologically agonizing to extubate her the next day. They say that a cat that walks across a hot stove will never do so again. It also will not walk on a cold stove again. This psychology deserves a post of its own.)
When I tweeted the image attached to this post announcing that the patient (and many like her) had been successfully extubated, there was less incredulity than I expected, but an astute follower asked – “Well, then, how do you decide whom and when to extubate?” I admit that I do not have an algorithmic answer to this question. Experts in opposing camps of decision psychology such as Kahneman and his adherents in the heuristics and biases camp and Gary Klein, Gird Gigerenzer and others in the expert intuition camp could have a heyday here, and perhaps some investigation is in order. I can summarize by saying that it has been an evolution over the past 10 or so years. I use everything I learned from the conventional, physiologic, algorithmic, protocolized, data-driven, evidence-based approach to evaluate a patient. But I have gravitated to being more sensitive, to capture those patients that the predictors say should fail, and I give them a chance – a “trial of extubation.” If they fail, I reintubate quickly. I pay careful attention to respiratory parameters, mental status, and especially neuromuscular weakness, but I integrate this information into my mental map of the natural history of the disease and the specific patient’s position along that course to judge whether they have even a reasonable modicum of a chance of success. If they do, I “bite the bullet and pull it.”
I do not eschew data, I love data. But I am quick to recognize their limitations. Data are generated for many reasons and have different values to different people with different prerogatives. From the clinician’s and the patient’s perspective, the data are valuable if they reduce the burden of illness. I worry that the current data and the protocols predicated on them are failing to capture many patients who are able to breathe spontaneously but are not being given the chance. Hard core evidence based medicine proponents and investigators need not worry though, because I have outlined a testable hypothesis: that a “trial of extubation” in the face of uncertainty is superior to the use of prediction tests and protocols. The difficult part will be determining the inclusion and exclusion criteria, and no matter what compromise is made uncertainty will remain, reminding us that science is an iterative, evolving enterprise, with conclusions that are always tentative.
I hope readers will weigh in; this blog will be aimed to provoke discussion.
Blog#1: Opiates and us
Two years ago I “landed” in Niantic/New London, where I grew up, to practice 7 days of critical care and 12 days of primary care each month in a non-academic setting. After 20 years of academics, teaching and research, my wife and friends were sure it would be a bad move. But it’s been great fun and revelatory. I am likely among the few (oxymoronic) primary care intensivists in the country, and was struck immediately by the frequency of patients on prescription opiates and benzodiazepines. I’d served in some awfully tough cities (Hartford, south Chicago, Bridgeport) but the dimensions of substance, and especially opiate, abuse were staggering. Colleagues from other academic, big-city settings agree the problem in Southeast CT dwarfs our previous gigs.
Then came a spate of tragic heroin – or more exactly fentanyl-laced – overdose cases in New London. One rotation in a 48 hour period I had two 40’ish year olds brought in mostly brain dead. While complex social and economic convulsions certainly contributed to increasing opiate abuse nationally, and more so in New London county, some healthcare experts have offered a more reflective synthesis. In the 1990’s the medical establishment and laypress chastised physicians for treating pain insufficiently. “Patients won’t become addicted,” we were assured. And “pain is the 5th vital sign,” bone fide and required by hospital accreditors. Landmark articles in JAMA trumpeted the gross under-treatment of pain in patients with cancer and AIDS. As recently as 2005, Jane Brody wrote an article in The New Times entitled “When It Comes to Severe Pain, Doctors Still Have Much to Learn.” An “expert” was quoted: “Fear and lack of knowledge of these drugs prevent many doctors from prescribing them for people whose pain is caused by anything other than cancer.” And (eye-candy) PHARMA reps sold us on the safety of prescription opiates as they filled their coffers at the expense of society.
As a result, physicians, nurses and hospitals embraced this concept and, over a relatively brief span of 10 years, opiates were increasingly used first (rather than last) to treat all manner of pain, for indefinite periods. (The floodgates similarly opened for benzos as intensivists were brain-washed to use enormous doses that unarguably harmed patients.) Clinicians with no formal training in pain management were left to fathom when it was reasonable to stop opiates. When patients continued to complain of pain and/or had become increasingly tolerant or addicted to opiates they were left in a conundrum: how to withdraw them? Withdrawal can be a life-threatening process and very few clinicians know how. Meanwhile patients began to learn that they could obtain much more potent opiates at relatively low prices, illegally in the form of heroin. Our Governor Malloy acknowledged the problem and began to clamp down on opiate prescriptions starting January 1, 2016. But with so many patients now addicted, and so few addiction specialists, it is not clear that once cut off from prescriptions, these patients won’t, in desperation, seek heroin.
In our rush to compassionate care, we clinicians contributed to this problem. As a new primary care physician, I am struck by the number of patients – many in their 70’s and 80’s – who are habituated to opiates. One 80 year old admitted recently: “You can’t stop my oxycodone; I’m an addict,” she said half-jokingly. But it is the current fate of too many of our neighbors; and threatens too many of our children.
While the President, congressmen and governors have focused greater attention on this now- unavoidable problem, it needs to be a call to arms for physicians, patients and policy-makers. No single remedy is likely to fix this problem but consider:
- While doctors, nurses and physician assistants are being trained, we will never have enough pain and withdrawal experts to catch up with this problem. We must all agree to write new prescriptions for opiates for only very limited periods, informing patients when to expect no more. For those who truly have chronic refractory pain, primary care physicians need to work with pain specialists to apply all other modalities (e.g. pain patches, gels, non-steroidal medications, pain-modulating medications, physical therapy, electrical stimulation, anesthetic injections, etc.) with a goal of reducing or eliminating opiates.
- Patients who are already addicted must be convinced that only a small fraction of chronic pain patients truly need opiates forever; that opiates are a dead-end, appropriate for those who are dying, but harmful for all but a very few who wish to live fruitful lives.
- While we cannot all become withdrawal experts, there are new FDA-approved medications for withdrawing opiate addicts – whether heroin or prescription opiates. Each primary care provider, nay every physician who contributed to the epidemic, might consider taking the 4-8 hour courses to be licensed to administer these medications. If each of us aimed to withdraw all the patients we currently have who don’t need opiates, and a handful of others, we’d go a long way to addressing this problem.
- The Obama administration has earmarked $94 million to fortify opiate withdrawal programs in community health centers. But what about the multitude of non-indigent patients who are hooked, stranded, on opiates? The Market contributed to this problem and is a powerful mechanism to match supply and demand. If sufficient government monies are used to pay physicians to provide withdrawal services – i.e. a fair rate of reimbursement commensurate with the magnitude of the problem – clinicians will come. We need specific, well-remunerated codes for managing opiate withdrawal to draw more clinicians into the solution.
We physicians inadvertently contributed to the opiate crisis – with all good intentions – and now can become part of the solution. Else too many or our neighbors will suffer, enslaved by an epidemic of Medicine’s creation. Too many of our children will fall into this abyss until we own the problem.