Category: Quality

The Grim Outcomes Brigade

This study aims to answer the critically important question we want to answer for every single patient – if we send them home, will they come back dead?

This is a retrospective medical record review of Kaiser health plan patients presenting to Kaiser Permanente hospitals in California who were discharged from the Emergency Department – and then died within 7 days.  They excluded hospice, DNR, and DNI patients from this analysis, and identified 446,120 discharges over the course of two years resulting in 203 deaths (0.05%).  These authors performed a qualitative chart review of 61 patients evaluating for common features.

A few highlights from their common themes:

  • Unexplained persistent acute mental status change – probably a difficult discharge to justify.
  • Documentation of “ill-appearing” or “moderate distress” – certainly some folks improve, but not the 89 year-old reviewed by these authors.
  • Abnormal vital signs – the classic cautionary tale, which ought to have been easier in a hypoxic 69 year-old.
  • Misdiagnoses due to inadequate differential diagnosis – the other classic, unavoidable, human error.
  • Admission plan changed – a potentially risky play to discharge when another physician feels a patient warrants admission.

This is simply a basic descriptive study.  The elements described herein should not be implied to be specific causal factors, but hypothesis generating for future work.  It is, however, a fascinating topic and part of the ultimate question at the root of nearly all our patient encounters.

“Qualitative Factors in Patients Who Die Shortly After Emergency Department Discharge”

http://www.ncbi.nlm.nih.gov/pubmed/24033620

Death From a Thousand Clicks

The modern physician – one of the most highly-skilled, highly-compensated data-entry technicians in history.

This is a prospective, observational evaluation of physician activity in the Emergency Department, focusing mostly the time spent in interaction with the electronic health record.  Specifically, they counted mouse clicks during various documentation, order-entry, and other patient care activities.  The observations were conducted for 60-minute time periods, and then extrapolated out to an entire shift, based on multiple observations.

The observations were taken from a mix of residents, attendings, and physician extenders, and offer a lovely glimpse into the burdensome overhead of modern medicine: 28% of time was spent in patient contact, while 44% was spent performing data-entry tasks.  It requires 6 clicks to order an aspirin, 47 clicks to document a physical examination of back pain, and 187 clicks to complete an entire patient encounter for an admitted patient with chest pain.  This extrapolates out, at a pace of 2.5 patients per hour, to ~4000 clicks for a 10-hour shift.

The authors propose a more efficient documentation system would result in increased time available for patient care, increased patients per hour, and increased RVUs per hour.  While the numbers they generate from this sensitivity analysis for productivity increase are essentially fantastical, the underlying concept is valid: the value proposition for these expensive, inefficient electronic health records is based on maximizing reimbursement and charge capture, not by empowering providers to become more productive.

The EHR in use in this study is McKesson Horizon – but, I’m sure these results are generalizable to most EHRs in use today.

“4000 Clicks: a productivity analysis of electronic medical records in a community hospital ED”
http://www.ncbi.nlm.nih.gov/pubmed/24060331

Reforming Clinical Guidelines

If you’ve been following my various linkaways on this blog over the last couple months, you’ve seen me highlight an investigative report by Jeanne Lenzer regarding some of the controversial recent clinical guidelines.  Beyond that, however, is Part 2 of this project – where a team headlined by Jerome Hoffman, Curt Furburg, and John Ioannidis came up with a set of evaluation criteria for worrisome conflicts-of-interest in clinical guidelines.

These evaluation criteria, a set of “red flags”, chosen over months of debate:

  • Sponsor(s) is a professional society that receives substantial industry funding;
  • Sponsor is a proprietary company, or is undeclared or hidden
  • Committee chair(s) have any financial conflict
  • Multiple panel members have any financial conflict
  • Any suggestion of committee stacking that would pre-ordain a recommendation regarding a controversial topic 
  • No or limited involvement of an expert in methodology in the evaluation of evidence
  • No external review
  • No inclusion of non-physician experts/patient representative/community stakeholders

As you can see, the list includes several types of sponsorship COI, as well as other cautions meant to ensure objectivity and patient-centric recommendations.  Whether this set of “red flags” becomes a useful tool for future guideline evaluation yet remains to be seen.  As should come as a surprise to no one, the new ACEP/AAN tPA clinical policy – evaluated independently of the guidelines Working Group – garners an unimpressive six “red flags” and a “caution”.

William Mallon, David Newman, Kevin Klauer, myself, and many others contributed to this project.

“Ensuring the integrity of clinical practice guidelines: a tool for protecting patients”
http://www.bmj.com/content/347/bmj.f5535

CTCA Is Better Than Wishing & Hoping

CT coronary angiograms have infiltrated the Emergency Department, with trials such as ACRIN-PA, CT-STAT, and ROMICAT II demonstrating their utility – primarily sensitivity – for the rapid detection of coronary artery disease.  It comes as a surprise to no one that an angiogram demonstrating a total absence of coronary artery disease confers an excellent short-term prognosis.  The downside, of course, is cost, contrast, radiation, and the suggestion that low-risk patients might be harmed by additional, unnecessary testing.  However, enthusiasm for the procedure abounds.

This is an observational study from Thomas Jefferson University looking at consecutive Emergency Department patients referred for CTCA, prospectively collecting variables to calculate TIMI and GRACE risk scores.  No clearly defined primary outcome is provided, but it seems these authors aimed to demonstrate that CTCA would correctly detect severe coronary disease (>70% stenosis) and better prognosticate adverse outcomes than the TIMI and GRACE risk scores.  They enrolled 250 patients, lost 29 to follow-up, and reported six adverse cardiovascular events within 30 days – 2 MIs, 2 ACS, and 2 revascularizations.  All six were TIMI 1 or 2, had relatively middling GRACE scores, and had extensive CAD detected on CTCA.  Overall, 17 patients had significant CAD (>50% stenosis) detected, and increasing TIMI and GRACE scores did not correlate with its presence or absence.  Therefore, these authors feel CTCA is an appropriate diagnostic study and is superior to clinical assessment and risk scores.  They even go so far as to disparage Rita Redberg’s editorial in the New England Journal of Medicine that questioned whether any cardiovascular imaging was indicated before low- and intermediate-risk chest pain patients left the Emergency Department.

They seem, unfortunately, to turn a blind eye to their inability to appropriately select patients for imaging, with only a 6.8% yield for significant stenosis, fewer than half of whom even progressed to a cardiac outcome.  I also take issue with the 2 patients they classified as ACS – they didn’t receive revascularization and didn’t have an MI – so what were they?  Either way, we’re looking at great expense in a cohort with only 1.4-2.4% incidence of positive cardiac outcome within 30 days.  Additionally, the comparison to TIMI and GRACE is a straw-man comparison to instruments proven to have poor predictive value in Emergency Department populations.

This is simply another trip down the quixotic zero-miss path to destruction, even going so far as to fearmonger with liability claim cost statistics.  Rather, it’s clear we’re simply doing a terrible job searching for the needle in the haystack – and the vast majority of these patients are safe for appropriate follow-up after initial Emergency Department assessment.  Rather than use this article to justify admission for CCTA, I would present this data to your patients in the context of shared decision-making and educate them regarding the high costs, abysmal yield, and poor specificity of the test used in this context.

“Cardiac risk factors and risk scores vs cardiac computed tomography angiography: a prospective cohort study for triage of ED patients with acute chest pain”
http://www.ncbi.nlm.nih.gov/pubmed/24035047

Local Variation in CT Use

Tell me if this sounds like your department – some folks, every time you receive sign-out, the radiologist has billed for a new BMW.  Other times, there’s an uncomfortable disuse of CT, even in the ticking time bombs of the elderly.  We all have that anecdotal feel for the variation in practice, and these authors have gone ahead and quantified it.

This is a descriptive, observational study of a single-center in Virginia evaluating individual physician CT scan use.  Overall, the department performed CT scans on 23.8% of the nearly 200,000 patient visits during the study period.  Across the 49 Emergency Physicians tracked during the study period – yes, the variation is exactly as one would expect.  The most frequent utilizers ordered CTs on nearly one third of patients, while the least frequent users only 1 in 8.

There are a couple individually coded information graphics embedded in the paper that demonstrate some extremely striking variation.  For example, as coded by chief complaint – a few physicians ordered CT scans on >60% of headache patients, while an even greater number ordered zero.  60% vs. zero!  While some practice variation is obviously acceptable in evolving practice and heterogenous patient substrate, this clearly reflects some element of underlying low-quality care.

As poorly implemented as they may be, the conception behind prior quality measures for CT use certainly has merit.  Quality measures aimed at increasing testing yield – ideally coupled with liability protections for Emergency Physicians – are likely to have increasing roles moving forward.

“Variation in use of all types of computed tomography by emergency physicians”
http://www.ncbi.nlm.nih.gov/pubmed/23998807

Still Looking For Positive EHR Effects

Our health system just underwent an upgrade from the 2009 version of an EHR to the 2012 version.  The color scheme is a little different.  The painfully cluttered workflow is not significantly changed.  I’m sure there are many Very Important Features – likely relating to burdensome documentation regulations – but, from a clinical standpoint, it still feels like we’re working with Windows 3.1.

But, we suffer this hacked together kludge because of the promise for tangible improvements in quality of care.  One area that has markedly changed with the advent of EHR is the ability to obtain significant medical histories on our patients – without the need to rely on the imperfect patient interview.  The hope of these authors was that, if they compared patients for whom they had complete records established in the EHR to patient who were EHR naive at their facility, they’d be able to demonstrate improvements in at leasts surrogate markers for patient-oriented outcomes.

Looking retrospectively at three EDs covering 13,227 patient visits, these authors found essentially statistical noise.  Comparing multiple outcomes including hospitalization, ED LOS, quantity lab orders, and hospital mortality, they found inconsistently distributed variation that is more likely attributed to unmeasured confounders than any element of the EHR itself.

Like most folks using EHRs, I suspect there are small, difficult-to-measure improvements in healthcare delivery.  Interoperability and centralized data sources would contribute vastly, I hope, to reduced testing and admission rates without adverse effects on outcomes.  However, we’re still waiting for proof.

“The impact of electronic health records on people with diabetes in three different emergency departments”
http://www.ncbi.nlm.nih.gov/pubmed/23842938

“NEXUS Chest” Decision Instrument

Low-yield radiography in the setting of trauma is pervasive and costly, but, unfortunately guidance regarding appropriateness is poor.  The NEXUS group previously derived a chest imaging decision instrument, and this newly published article describes the validation study.

The good:  98.8% (CI 98.1-99.3%) sensitivity for any thoracic injury on imaging, and 99.7% (CI 98.2-100%) sensitivity for injuries of major clinical significance.

The really, really bad:  13.3% (CI 12.6-14.1%) specificity for thoracic injury or 12.0% (11.3-12.6%) specificity for major significance.

And, these numbers are probably subject to some limitations, considering about half the patients only received chest x-ray, rather than chest CT.  That said, the injuries missed by x-ray are not likely of major clinical significance – and the patients selected for x-ray alone in the run of standard practice were likely selected for a low pretest probability of serious injury, regardless.

The authors suggest their instrument, despite it’s terrible specificity, still represents a valuable rule-out option, theorizing that even the small reduction in imaging this rule represents is beneficial.  However, as we’ve covered before, one-way decision instruments are subject to cognitive bias and use as two-way rules, which may paradoxically increase imaging – although, in trauma, it’s hard to imagine a way to order more.  Careful adoption of this instrument will be required – perhaps only after clinical evaluation as a screening decision-support question in the CPOE, asking one last time if the patient possibly meets this very-low-risk criteria prior to ordering.

The exclusion from very-low-risk criteria, by the by:

  • Older than 60 years
  • Rapid deceleration mechanism (fall >20 ft, MVC >40mph)
  • Chest pain
  • Intoxication
  • Abnormal mental status
  • Distracting painful injury
  • Tenderness to chest wall palpation

“NEXUS Chest – Validation of a Decision Instrument for Selective Chest Imaging in Blunt Trauma”
http://www.ncbi.nlm.nih.gov/pubmed/23925583

Post-Arrest Catheterization Delusions

We have, yet again, another favorable publication espousing the benefit of cardiac catheterization after cardiac arrest.  There is not a great deal of ambiguity regarding the management of post-arrest STEMI.  However, the cohort these authors examine – those without obvious cardiac cause for arrest – is harder to to judge.

Unfortunately, this article is the same level of evidence as the prior publications in this field – by which I mean, practice change followed by retrospective, observational case-series.  These authors look back at their cohort cohort of VT/VF that was not STEMI – a reasonable initial stratification based on presenting rhythm and likely association with acute coronary syndrome.  Of 269 patients meeting this definition, 122 underwent early catheterization and 147 did not.  The outcomes were more favorable in the cohort that underwent catheterization, and thus, the conclusion:

“In comatose survivors of cardiac arrest without STEMI who are treated with TH, early CC is associated with significantly decreased mortality.”

But, these authors are unable to pin down exactly what element of post-arrest care in the catheterization lab leads to this decreased mortality.  Only 26.2% of patients undergoing early catheterization had a lesion amenable to intervention (the authors call this level of incidence “high” – hum), and intervening on a coronary lesion conferred no specific survival advantage.  Therefore, it’s not the PCI that benefited these patients.  There was an increased incidence of post-resuscitation shock in the catheterization cohort, and these underwent left-ventricular support more frequently – which may or may not have resulted in improved outcomes.  Furthermore, the median time to therapeutic hypothermia in the catheterization cohort was an hour faster as well – suggesting this baseline difference in treatment may have influenced cognitive outcomes.

Unfortunately, retrospective studies like this suffer critically from selection bias – patients in the arm receiving cardiac catheterization may have had other unreported features favorable for cognitively intact outcomes, leading clinicians to treat them differently/more aggressively.  It would be inappropriate to generalize this observational association with causation and send all post-arrest to catheterization.  Certainly, some subset of VT/VF arrest benefits from early cardiac catheterization, but this study unfortunately does little to delineate which.

“Early cardiac catheterization is associated with improved survival in comatose survivors of cardiac arrest without STEMI”
www.ncbi.nlm.nih.gov/pubmed/23927955‎

Guidelines For Sale

In a world of complex and sometimes conflicting literature, many physicians and professional societies rely on experts to synthesize the evidence and produce general guidelines supporting best practices.  To evaluate the potential for sponsorship bias, these authors perform a cross-sectional study of recently published national and international guidelines associated with the greatest healthcare expenditures.

In line our with our recent coverage of the BMJ investigative report, 75% of guideline committee members disclosed relevant financial conflicts of interest.  The astute reader may judge for themselves whether these most frequently reported COIs are relevant:

  • ADHD: manufacturers of methylphenidate HCl and atomoxetine
  • Alzheimers disease:  manufacturers of solanezumab and donepezil HCl
  • Anemia/CKD:  manufacturer of darbepoetin alfa
  • Asthma:  manufacturers of fluticasone propionate and montelukast sodium
  • Bipolar/depression:  manufacturers of duloxetine, olanzepine, sertraline, and ziprasadone.
  • Cholesterol:  manufacturers of simvastatin and rosuvastatin
  • COPD:  manufacturers of budesonide & fometerol, tiotropium bromide, and fluticasone propionate
  • Hypertension:  manufacturers of irbesartan, losartan, and amlodipine besylate/benazepril HCl
  • Myocardial infarction:  manufacturers of rosuvastatin, rivaroxaban, and alteplase
  • Multiple sclerosis:  manufacturers of interferon beta and terifunomide
  • Rheumatoid arthritis:  manufacturers of certolizumab pegol, adalimunab, and abatacept

I’m sure these guidelines reliably provide funding-agnostic recommendations.  We might as well just have a bidding war between drug companies to vie for favored product status.

“Expanding Disease Definitions in Guidelines and Expert Panel Ties to Industry: A Cross-sectional Study of Common Conditions in the United States”
http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001500

U.S. Physicians are Awful at Prescribing Antibiotics

…and the Emergency Department is one of the worst offenders.

This is an analysis of the National Hospital Ambulatory Medical Care Survey, a representative sampling of ambulatory settings across the United States.  These authors simply reviewed all the antibiotic prescriptions and diagnosis codes for adult visits to offices, outpatient departments, and Emergency Departments.  10% of visits result in antibiotic prescriptions – and 61% of these prescriptions were broad-spectrum agents (amoxicillin/clavulanate, quinolones, etc.).  The largest category of antibiotic prescribing was for acute respiratory infections – and only 32% of those prescriptions were for diagnosis codes where antibiotics were typically indicated.  88% of respiratory diagnoses for which antibiotics were rarely indicated (e.g., bronchitis) received a broad-spectrum antibiotic.

This is retrospective, and the NHAMCS database has limitations – but this is farcical.  We’re passing out antibiotics without regard to the consequences – and we’re overusing broad-spectrum agents when narrow-spectrum agents are likely appropriate.  We’re far behind Europe in antibiotic stewardship, and the end result is certainly net population harm from over-treatment and induction of microbial resistance.

And, this doesn’t even account for pediatric visits – which are probably even worse.

Tragically, physician reimbursement is tied to patient satisfaction – or is an emphasized part of a healthcare business model in for-profit settings – and the evidence clearly indicates patients are more satisfied when they receive antibiotics.(pubmed, pubmed, archives of pediatrics)

Yet another example of perverted incentives degrading medical practice.

“Antibiotic prescribing for adults in ambulatory care in the USA, 2007 – 09”
www.ncbi.nlm.nih.gov/pubmed/23887867‎