Category: Policy

What are Children’s Lives Worth (to Save)?

This article regarding the cost of upgrading emergency departments to be “ready” for sick children has been bouncing around in the background since its publication, with some initial lay press coverage.

The general concept here is obviously laudable and the culmination of at least a decade of hard work from these authors and the team involved – with the ultimate goal of ensuring each emergency department in the country is capable of caring for critically unwell children. The gist of this most recent publication builds upon their prior work to, effectively, estimate the overall cost (~$200M) of improving “pediatric readiness”. Using that total cost, they then translate this into humanizing terms by referencing the total cost per child it might require in different states, and the number of pediatric lives saved annually.

As can be readily gleaned from this sort of thought experiment, these estimates rely upon a nested set of foundational assumptions, all of which are touched upon by prior work by this group. There are surveys of subsets of emergency departments regarding “readiness“, which involve questions such as the presence of pediatric-sized airway devices and staff dedicated to upkeep of various pediatric support. Then, they use these data and salary estimates to come up with the institutional costs of readiness. Then, they have another set of work looking at the odds ratios for increased poor outcomes at departments whose “readiness” is in the lowest percentiles, and this work is extrapolated to determine the lives saved.

Each of these pieces of work, in isolation, is reasonable, but represents a bit of a house of cards. The likelihood of imprecision is magnified as the estimates are combined. For example, how direct is the correlation between “readiness” based on certain equipment and pediatric survival, if the ED in question is a critical access hospital with low annual census? Is the cost of true clinical readiness just a part-time FTE of a nurse, or should it realistically involve the costs of skill upkeep for nurses and physicians with education or simulation?

I suspect, overall, these data understate the costs and overstate the return on investment. That said, this is still critical work even just to describe the landscape and take a stab at the scope of funding required. Likely, the best next step would be to target specific profiles of institutions, and specific types of investment, where such investment is likely to have the highest yield – as a first step on the journey towards universal readiness.

“State and National Estimates of the Cost of Emergency Department Pediatric Readiness and Lives Saved”
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2825748

Who Are Buying Emergency Physicians?

It’s CMS Open Payments Database time again, updated for 2017. Sadly, it turns out you or at least one of your closest colleagues is a witting or unwitting puppet of the pharmaceutical industry: a full 35.4% of practicing U.S. emergency physicians received payments from industry last year.

The details:

  • The median payment was $18 – 90% of you just got lunch (or dinner)(or less).
  • Over 75% of emergency physicians in Mississippi were the recipient of some industry payment.
  • Ethicon Endo-Surgery and Janssen Pharmaceuticals were the largest of many contributors, and Xarelto, Eliquis, Activase, and Pradaxa were the most frequently cited products.
  • There were 35 EPs receiving industry sponsored research payments, primarily from device manufacturers – Covidien, Taro, and Zoll.

That said, these data also only scratch the surface of accountability, as about half of payments could not be associated with a product, and reporting to the OPD does not include other general grants and payments to organizations, rather than individuals.

And now you know, and knowing is half.

“Analysis of current financial relationships between emergency physicians and industry”
https://www.ajemjournal.com/article/S0735-6757(18)31001-5/abstract

Clinical Policy: Sanity Returns to ACS

This may be the most important recent sentence in modern emergency medicine:

“… based on limitations in diagnostic technology and the need to avoid the harms associated with false-positive test results, the committee based its recommendations on the assumption that the majority of patients and providers would agree that a missed diagnosis rate of 1% to 2% for 30-day MACE in NSTE ACS is acceptable.”

It’s no longer the domain of rogue podcasters and throwaway magazine editorialists to declare our zero-miss culture destructive and self-defeating – it’s finally spelled out in black & white by our speciality society. This is not a license to kill, of course, but it is now utterly reasonable to feel as though the wind is at your back when sending an appropriately-evaluated patient home.

This clinical policy statement does not address terribly many questions, but it does jam a lot of evidence into one document in their review. Specifically, these authors ask:

1. In adult patients without evidence of ST-elevation ACS, can initial risk stratification be used to predict a low rate of 30-day MACE?

In short, yes. These authors recommend HEART as their decision instrument du jour, but also acknowledge other scores that simply do not yet have enough diverse evidence to support their use. Interestingly, they also note clinical gestalt may be just as good as any decision instrument, at least when the ECG and troponin are negative for new ischemia. Again, more prospective evidence would be required to formally enshrine such a recommendation into a clinical policy statement.

2. In adult patients with suspected acute NSTE ACS, can troponin testing within 3 hours of ED presentation be used to predict a low rate of 30-day MACE?

Here the authors have only Level C recommendations, which means their recommendations are based on low levels of evidence. Overall, they are weakly in favor of using of high-sensitivity troponins alone, or repeat conventional troponin testing as part of a risk-stratification or accelerated diagnostic pathway.

3. In adult patients with suspected NSTE ACS in whom acute MI has been excluded, does further diagnostic testing (eg, provocative, stress test, computed tomography [CT] angiography) for ACS prior to discharge reduce 30-day MACE?

Please no: “Do not routinely use further diagnostic testing (coronary CT angiography, stress testing, myocardial perfusion imaging) prior to discharge in low-risk patients in whom acute MI has been ruled out to reduce 30-day MACE.”  Take that, CCTA proponents.  They give an expert consensus recommendation of 1 to 2 week primary care follow-up when feasible, or consideration of observation when no follow-up is possible.

The fourth question posed deals with use of P2Y12 and
glycoprotein IIb/IIIa inhibitors in the ED, and is met basically with a shrug.

So!  Go forth and provide good medical care – specifically, high-value medical care, further freed from the mental oubliette of zero-miss.

“Clinical Policy: Critical Issues in the Evaluation and Management of Emergency Department Patients With Suspected Non–ST-Elevation Acute Coronary Syndromes”
https://www.ncbi.nlm.nih.gov/pubmed/30342745

Dialysis Purgatory

This little article is not terribly generalizable and the results are eminently predictable – but this barbaric practice was my daily routine a couple years ago while working in Houston.

To received routinely scheduled dialysis, someone must, of course, pay for it. For those U.S. citizens without the means to pay, various federal mechanisms provide coverage. For non-U.S. citizens in this country without the means to pay, there is no external payor source – unless “necessary for the treatment of an emergency medical condition.” Therefore, many facilities simply restrict dialysis to non-citizen patients in extremis.

As you might expect, this is bad and bad for you. This retrospective cohort study follows 5-year survival and resource utilization, comparing those at hospitals where non-U.S. citizens could be eligible for scheduled dialysis with those at facilities where only emergency dialysis was available. The sample sizes are small – 169 in the “emergency-only” cohort and 42 in “standard” – but at 5 year follow-up, over half the “emergency-only” cohort had died, as compared with about 10% of the standard hemodialysis. Various statistical analyses and propensity matching further quantify the exact excess hazard of emergency dialysis.

Patients receiving emergency dialysis received, obviously, fewer sessions per month – 6.2 instead of 10.3. However, these savings are potentially offset by a ten-fold increase in acute care days, probably associated with those episodes of emergency dialysis. In the most morbid sense, unfortunately, total cost-savings probably favor the emergency dialysis cohort owing to the greatly increased mortality.

There are uncertainties and holes in these sorts of retrospective studies, particularly in a cohort whose deaths are potentially not documented in our national registries. The face validity for the overall findings is strong, however, even if the specific numbers are not reliable.

Regardless, just as a manner of respecting basic human decency, it is simple cruelty to layer this additional suffering onto the already miserable state of being dialysis-dependent. All feasible efforts should be made to provide access to regular dialysis, considering the burden on the health system infrastructure is likely similar.

“Association of Emergency-Only vs Standard Hemodialysis With Mortality and Health Care Use Among Undocumented Immigrants With End-stage Renal Disease”
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2665387

On Anesthesiology Knows Sedation

“These guidelines are intended for use by all providers who perform moderate procedural sedation and analgesia in any inpatient or outpatient setting …”

That is to say, effectively by fiat, if you perform procedural sedation, these guidelines apply to YOU.

This is a publication by the American Society of Anesthesiologists, and sponsored by various dental and radiology organizations. This replaces a 2012 version of this document – and it has changed for both better and worse.

Falling into the “better” column of this document, this guideline no longer perpetuates the myth of requiring a period of fasting prior to an urgent or emergent procedure. Their new recommendation:

“In urgent or emergent situations where complete gastric emptying is not possible, do not delay moderate procedural sedation based on fasting time alone”

However, some things are definitely “worse”. By far the largest problem with these guidelines – reflecting the exclusion of emergency medicine and critical care specialties from the writing or approving group – is their classification of propofol and ketamine as agents intended for general anesthesia. They specifically differentiate practice with these agents from the use of benzodiazepines or adjunctive opiates by stating:

“When moderate procedural sedation with sedative/ analgesic medications intended for general anesthesia by any route is intended, provide care consistent with that required for general anesthesia.”

These guidelines do not describe the care of patients receiving general anesthesia, but, obviously, we are not performing general anesthesia in the Emergency Department – and, I expect most hospitals do not credential their Emergency Physicians for general anesthesia. The impact of these guidelines in a practical sense on individual health system policy is unclear, particularly in the context of safe use of these medications by EPs for decades, but it’s certainly just one more pretentious obstacle to providing safe and effective care for our patients.

“Practice Guidelines for Moderate Procedural Sedation and Analgesia 2018”

http://anesthesiology.pubs.asahq.org/article.aspx?articleid=2670190

“The Newest Threat to Emergency Department Procedural Sedation”

https://www.ncbi.nlm.nih.gov/pubmed/29429580

Are We Killing People With 30-Day Readmission Targets?

Ever since the Center for Medicare and Medicaid Services announced their intention to penalize hospitals for early readmissions, folks have been worrying about the obvious consequences: would a focus on avoidance place patients at risk? Would patients best served in the hospital be pushed into other settings for suboptimal care?

That is the argument made in this short piece in the Journal of the American College of Cardiology. They look backwards at the last two decades of heart failure readmissions and short-term mortality, and take issue with the fundamental underlying premise of the quality measure, the inequities associated with the measure, and potential unintended harms. Their most illustrative example: when patients die outside the hospital within 30-days, paradoxically, they contribute to apparent improved performance in healthcare quality, as measured by 30-day readmission.

They back up their point by using the aggregate data analyzing readmissions between 2008 and 2014, published previously in JAMA, and focusing primarily on the heart failure component. In the original JAMA analysis, the evaluation paired individual hospital monthly readmission and risk-adjusted mortality, and were unable to identify an increased risk of death relating to reductions in 30-day readmissions. These authors say: too much tree, not enough forest. In the decade prior to announcements of 30-day readmission penalties, 30-day heart failure mortality had dropped 16.2%, but over the analysis period, 30-day heart failure mortality was back on the rise. In 2008 the 30-day mortality was 7.9% and by 2014 it was up to 9.2%, a 16.5% increase, and an even larger increase relative to the pre-study trend with decreasing mortality.

These are obviously two very different ways of looking at the same data, but the implication is fair: those charged with developing a quality measure should be able to conclusively demonstrate its effectiveness and safety. If any method of analysis raises concerns regarding the accepted balance of value and harm, the measure should be placed on a probationary status while rigorous re-evaluation proceeds.

“The Hospital Readmission Reduction Program Is Associated With Fewer Readmissions, More Deaths”
http://www.sciencedirect.com/science/article/pii/S0735109717393610

Is 3.3% Really the Avoidable Number?

Much has been made about “avoidable” Emergency Department visits – something, as physicians, we are anecdotally all-too-familiar – but the exact scope of the problem has been difficult to quantify. If it were easy, after all, the range of estimates for avoidable visits would not encompass the spread between 4.8% and 90%.

This is another shot at defining avoidable, this time using a very restrictive definition. An avoidable ED visit occurs when a patient is discharged home, and:

  • No tests are performed
  • No procedures are performed
  • No medications are administered or prescribed

These authors utilize the National Hospital Ambulatory Medical Care Survey (NHAMCS) for years 2005–2011, and find an estimated 3.3% of ED visits met those criteria. The most common discharge diagnoses included those related to alcohol use, back pain, throat pain, upper respiratory symptoms, dental issues, and mental health issues.

But, the true net result of this analysis is, unfortunately, it simply grows our estimate for avoidable ED visits to an even-more-ridiculous range between 3.3% and 90%. This definition lends itself far more to convenience for data analysis than face validity as a surrogate for avoidable. Clearly, a lack of testing or medication administration does not indicate a life- or limb-threatening condition has not been ruled out by expert clinical examination and reasoning. Conversely, ordering a test or administering a medication does not indicate the level of service of an ED was necessary, or the ideal venue for care delivery.

Given the limitations of the data set, this is a reasonable approach to add to the discussion of the types of potentially avoidable ED visits. However, I expect to see this 3.3% number cited frequently in isolation without acknowledging the underlying definitions or methods for derivation.  A better title for this paper?  How about: “ED visits resulting in neither treatment nor testing: a descriptive analysis” – the word “avoidable” should be omitted.

“Avoidable emergency department visits: a starting point”

https://doi.org/10.1093/intqhc/mzx081

The Futility of NSAIDs for Back Pain?

This article filled with reproach for non-steroidal anti-inflammatories was highlighted in a New England Journal of Medicine Journal Watch and on Twitter – a wistful treatise remarking on the general ineffectiveness of pharmacologic analgesics. “Nothing works!” accompanied by a general gnashing of teeth and writhing on invisible flames.

But – does this meta-analysis actually reach such a conclusion? Examine the first few words in their conclusion:

NSAIDs are effective for spinal pain …

Off to a good start! But, the catch:

… but the magnitude of the difference in outcomes between the intervention and placebo groups is not clinically important.

These authors pool the results of 35 randomized, placebo-controlled trials for “spinal pain”, which is to say undifferentiated pain relating anatomically to any part of the spine. These trials comprised 6,065 participants – or, if you do the math, an average of 173 patients per trial, nearly all of them performed over a decade ago. The pooled effects of these trials all favored NSAIDs – but, as the authors mention, the absolute magnitude of effect on pain scales was a the edge of their threshold for clinical significance. The authors defined a difference of 10 points on a 100-point scale as clinically important, but most of their pooled results landed between -7 and -16, favoring NSAIDs over placebo. With these small samples, generally moderate GRADE quality, and moderate to high heterogeneity between the pooled results, there is a lot of fuzziness around their ultimate conclusion.

These authors do many, other, exploratory analyses, and it is reasonable to suggest the limitations inherent to each render any conclusions unreliable. Adverse events, as reported, were similar between groups – excepting for increased gastrointestinal adverse events, most of which were non-serious. The authors report this difference as a relative risk of 2.5 for GI side effects in their comparison, but the absolute differences are on the order of an excess of 1 in 100.

This is probably much ado about nothing. Their perspective is not inaccurate, per se, but these trials do find a consistent benefit to NSAIDs. The value judgment here on clinical effectiveness probably misses the mark, particularly considering these are inexpensive, readily available, with few adverse effects in short-term use. I would probably argue it is easier to defend a position they still have utility in multi-modal pain control regimens, rather than to conclude they be consigned to the rubbish bin.

“Non-steroidal anti-inflammatory drugs for spinal pain: a systematic review and meta-analysis”

https://www.ncbi.nlm.nih.gov/pubmed/28153830

 

Blood Cultures Save Lives and Other Pearls of Wisdom

It’s been sixteen years since the introduction of Early Goal-Directed Therapy in the Emergency Department. For the past decade and a half, our lives have been turned upside-down by quality measures tied to the elements of this bundle. Remember when every patient with sepsis was mandated to receive a central line? How great were the costs – in real, in time, and in actual harms from these well-intentioned yet erroneous directives based off a single trial?

Regardless, thanks to the various follow-ups testing strict protocolization against the spectrum of timely recognition and aggressive intervention, we’ve come a long way. However, there are still mandates incorporating the vestiges of such elements of care –such as those introduced by the New York State Department of Health. Patients diagnosed with severe sepsis or septic shock are required to complete protocols consisting of 3-hour and 6-hour bundles including blood cultures, antibiotics, and intravenous fluids, among others.

This article, from the New England Journal, looks retrospectively at the mortality rates associated with completion of these various elements. Stratified by time-to-completion following initiation of the 3-hour bundle within 6 hours of arrival to the Emergency Department, these authors looked at the mortality associations of the bundle elements.

Winners: obtaining blood cultures, administering antibiotics, and measuring serum lactate
Losers: time to completion of a bolus of intravenous fluids

Of course, since blood cultures are obtained prior to antibiotic administration, these outcomes are co-linear – and they don’t actually save lives, as facetiously suggested in the post heading. But, antibiotic administration was associated with a fraction of a percent of increased mortality per hour delay over the first 12 hours after initiation of the bundle. Intravenous fluid administration, however, showed no apparent association with mortality.

These data are fraught with issues, of course, relating to their retrospective nature and the limitations of the underlying data collection. Their adjusted model accounts for a handful of features, but there are still potential confounders influencing mortality of those who received their bundle completion within 3 hours as compared to those who did not.  The differences in mortality, while a hard and important endpoint, are quite small.  Earlier is probably better, but the individual magnitude of benefit will be unevenly distributed around the average benefit, and while a delay of several hours might matter, minutes probably do not.  The authors are appropriately reserved with their conclusions, however, only stating these observational data support associations between mortality and antibiotic administration, and do not extend to any causal inferences.

The lack of an association between intravenous fluids and mortality, however, raises significant questions requiring further prospective investigation. Could it be, after these years wandering in the wilderness with such aggressive protocols, the only universally key feature is the initiation of appropriate antibiotics? Do our intravenous fluids, given without regard to individual patient factors, simply harm as many as they help, resulting in no net benefit?

These questions will need to be addressed in randomized controlled trials before the next level of evolution in our approach to sepsis, but the equipoise for such trials may now exist – to complete our journey from Early Goal-Directed to Source Control and Patient-Centered.  The difficulty will be, again, in pushing back against well-meaning but ill-conceived quality measures whose net effect on Emergency Department resource utilization may be harm, with only small benefits to a subset of critically ill patients with sepsis.

“Time to Treatment and Mortality during Mandated Emergency Care for Sepsis”

http://www.nejm.org/doi/full/10.1056/NEJMoa1703058

Just the Cost of Doing Business

Good news, everyone!

In the past two decades, for virtually every specialty, the number of paid medical malpractice claims has decreased. Overall, for all specialties, the rate of payment has been halved, compared with the 1992-1996 timeframe. Neurosurgery, unfortunately, is still the “winner”, followed by plastic surgery, thoracic surgery, and obstetrics. The lowest rates were seen in psychiatry and pediatrics. Emergency medicine sits right in the middle, with 18.8 paid claims per 1,000 physician years.

The bad news, unfortunately, was that the claim amounts – including paid claims greater than $1 million – increased. Emergency Medicine paid claim amounts increased 26.1% to a mean of $314,052 in the most recent time period of analysis, an increase in line with the overall mean for all specialties. The largest jump in payout amounts was essentially a tie between dermatology, gastroenterology, pathology, and urology. Neurosurgery actually had one of the lowest payout increases – probably because they started from such lofty heights, already.

Types of malpractice alleged varied by specialty, with the expected variation between diagnostic error, surgical error, and treatment errors between the diagnostic and surgical specialties. Most (63.6%) of malpractice alleged in emergency medicine fell into alleged diagnostic error, while logically 73.3% of alleged error in plastic surgery fell under surgical error.

These data, from the National Provider Data Bank, only document payments made for written claims and do not include settlements or monies paid out by institutions. Whether these actually represent a friendlier environment for physicians, more aggressive approaches to settling claims, or a shifting of liability to corporate proxy is not clear. Regardless, even if it is a little of all three, the trend is probably moving in the right direction.

“Rates and Characteristics of Paid Malpractice Claims Among US Physicians by Specialty, 1992-2014”

http://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2612118