Category: Quality

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

Observation of Minor TBI Prevents Harms

This study regarding the observation of children following minor traumatic brain injury is a little bit oddly spun by its authors and the medical news.

As we all know, most children presenting to the Emergency Department for minor head trauma do not have a clinically significant injury.  Regardless, a significant portion of these children receive non-therapeutic cranial radiation to further assure parents and clinicians alike.  The PECARN group, a few years back, published a rough decision instrument to help classify ~50% of these patients as “very low risk” (<0.05% risk of TBI) to give clinicians a tool to obviate CT scanning.

This group at Boston Children’s prospectively evaluated clinicians’ use of immediate CT scanning versus delayed CT scanning (observation).  They find, of course, that observing children in the ED for a short period, rather than making an immediate decision regarding CT use, resulted in decreased use of CT.  Thusly, the press releases state “Waiting and Watching Can Reduce Use of Brain Scans for Kids in the Emergency Department“.

But, watching and waiting doesn’t benefit the children in this cohort – other than preventing avoidable harms.  The eight children who had CT scans showing clinically important injuries were easily identified by clinicians as requiring immediate CT.  The period of observation doesn’t change the short-term clinical outcome of any of the patients – it only “treats” the risk-aversion of clinicians and parents.  “Watching and waiting” may reduce scans – but discharging the entire observation cohort immediately would have reduced scans even further, without missed cTBI (although the study is underpowered to truly detect all events down to an appropriate “zero-miss” threshold).

While I agree this is an important clinical problem to address, I simply find an odd discordance between the patient-oriented features and the resource utilization-oriented outcome measured.

“Effect of the Duration of Emergency Department Observation on Computed Tomography Use in Children With Minor Blunt Head Trauma”
www.ncbi.nlm.nih.gov/pubmed/23910481

More Sales Representatives, More Stents

In this breaking news update: sales representatives sell things!  Thusly, their company stays in business, and the employment of the sales representative continues.

This is a retrospective review of a Canadian hospital’s cardiac catheterization practices, evaluating the association between presence of sales representatives for stent manufacturers and use of each company’s stents during PCI.  Each day, during normal business hours, potentially a single sales representative from one of five stent manufacturers could be present in the lounge or in one of three cardiac catheterization laboratories.  Certain manufacturers specialized in bare metal stents, drug-eluting stents, or antibody-coated stents.

Unsurprisingly enough, cases performed in the presence of a sales representative resulted in increased use of that particular representative’s stents.  Additionally, for cases where DES were deployed, on average, more stents were placed during PCI when a drug representative was present.  Increased stenting, increased per-patient average cost.

It is a retrospective review, and there are baseline differences between the indications for catheterization – but, I think the observed association is probably real.  The authors also note, after these promotional visits were discontinued, all variation in stent use disappeared.

Further evidence of the suggestibility of physicians to marketing influences – supporting efforts to expunge them from our practice settings.

“The impact of industry representative’s visits on utilization of coronary stents”
www.ncbi.nlm.nih.gov/pubmed/23895808‎

Half of What You Know is Wrong

…but we don’t know which half.  This highly entertaining study dredged the New England Journal of Medicine for the last decade, asking a simple question:  does new literature confirm or refute current practice?

They identified 1,344 articles concerning a specific medical practice.  Of these, 363 tested an established medical practice.  38% confirmed current practice, 40% rejected current practice, and 22% were inconclusive.  Examples of rejected medical practice included:

  • Primary rhythm control strategy in patients with atrial fibrillation.
  • The use of aprotinin during cardiac surgery.
  • Cyclooxygenase 2 inhibitors due to cardiovascular events.
  • Tight glycemic control vs. more permissive standards.
  • Benefit of stenting for patients with stable coronary disease.

…and so on.  It’s a fascinating list – and this is just one journal.

Of further interest, the majority of articles concerning specific medical practice concerned the development of a new medical drug or intervention, and most of these were positive.  I expect we shall see half of those similarly rejected by follow-up investigation in the next decade….

“A Decade of Reversal: An Analysis of 146 Contradicted Medical Practices”

Continuing Debate Over Thrombolysis

The debate spurred by Jeanne Lenzer’s report on conflicts of interest by guideline writers continues.

Drs. Grotta, Hoffman, Saver, Newman, Solomon, Klauer, Marchidann, Sandercock, Quinn and myself all contribute to the back-and-forth regarding the future of tPA in stroke, while Dr. Geisler and Bracken respond regarding the data for use of steroids in spinal cord trauma.  Some truly amazing responses by leading physicians on both sides of the issues.
“Why we can’t trust clinical guidelines”

We Can Cath You

Despite all the bad press the United States healthcare system gets, there is one incontrovertible truth: we’re the leading authority in cardiac catheterization.  If practice makes perfect, no one is closer to perfection than us.  Let’s not tarnish our procedural expertise with silly notions of appropriateness, shall we?

These authors from Canada – clearly, with a hometown bias – undertake a retrospective registry review comparing cardiac catheterizations from Ontario and New York state.  They observe New York state performs twice as many cardiac catheterizations per capita and wonder – are Americans twice as unhealthy, or are our cardiologists just twice as skilled at profiting from cardiac catheterization?

The review excludes patients known to have obstructive CAD, shock, recent MI, or unstable angina – which makes this essentially an elective cath cohort.  Overall, 30.4% of patients in New York were diagnosed with obstructive CAD on catheterization, compared with 44.8% in Ontario.  This higher diagnostic yield is unsurprising, considering the New York cohort had, by far, a lower predicted probability of obstructive CAD.  This reasonably supports the follow-up author conclusion Ontario does a superior job at selecting patients for the procedure.

I can’t believe they would imply U.S. healthcare delivery is somehow inefficient.

As Outside Hospital notes: We can cath you.

“Prevalence and Extent of Obstructive Coronary Artery Disease Among Patients Undergoing Elective Coronary Catheterization in New York State and Ontario”
www.ncbi.nlm.nih.gov/pubmed/23839750‎

Does Funding Source Influence Guidelines?

There’s been a little hullabaloo recently regarding the influence of financial conflicts-of-interest on guidelines – the result of a recent BMJ investigative report.  But, what effect do these conflicts truly have?  Is there any way to compare, side-by-side, a conflicted guideline with a non-conflicted guideline?

Why – yes!

In the very popular American Journal of Medical Quality comes this tiny gem, a comparison between two guidelines written just over a year apart.  Both guidelines describe treatment options for Primary Immune Thrombocytopenia, and were both published in the same journal.  One guideline was written by a financially untarnished societal group, while the other guideline was written by sponsored experts.  In addition, the sponsored guideline had supplemental assistance by a professional scientific writing group funded by pharma.

Table 4 is a lovely, side by side comparison of the major treatment recommendations.  Unsurprisingly, various thrombopoietin-receptor agonists and anti-D immunoglobulin received top billing in the sponsored guideline, while more conventional therapies were recommended in the non-sponsored guideline.

This article was, however, written by members of the non-conflicted guideline group – so, perhaps there’s some ulterior motive at work.  Regardless, at least, it’s a fascinating look at the tangible effects of financial conflicts-of-interest.

“Conflicts of Interest and Clinical Recommendations: Comparison of Two Concurrent Clinical Practice Guidelines for Primary Immune Thrombocytopenia Developed by Different Methods”
www.ncbi.nlm.nih.gov/pubmed/23550214

Too Much Admission Rate Variation

Anyone and everyone who works in the Emergency Department is aware there is a spectrum of individual practice.  Certainly, any resident currently in training frustratingly knows this all too well, and can easily predict the prevailing culture of their shift in advance depending on their supervising attending.

So, it comes as no surprise this review of 389,120 Emergency Department visits in a three hospital, single-system review shows substantial variation in admission rate.  There was, obviously, variation between hospitals – expected as different hospitals may have variable patient demographics.  But, within hospitals – and across all three sites – there was up to a 2.3-fold (21% to 49%) variation in admission rate.  As with all retrospective, observational studies, there are limitations inherent in the data set.  However, the authors attempted adjustments based on several factors without substantially altering the outcomes.

There is no data on patient outcomes – particularly as relevant to those discharged by physicians with the lowest admission rates.  Considering our culture of over-diagnosis and over-treatment, I expect, with further prospective or cross-sectional study, we would find the physicians with the lowest admission rates to have indistinguishable health outcomes from their peers.  The factors that contribute to this variation – as well as interventions to reduce the variation – require further study.

“Emergency Department Physician-Level and Hospital-Level Variation in Admission Rates”
www.ncbi.nlm.nih.gov/pubmed/23415741‎

The Overtreatment of Elderly UTIs

Urinalysis is frequently performed in elderly females presenting to the Emergency Department with non-specific symptoms – owing to the general trend of non-focal constitutional complaints failing to localize disease as age increases.  Understandably, then, this population is thoroughly subjected to increased diagnostic testing.

And, of course, if you run enough tests, you’ll find some “answers”.  The question, of course, is whether these “answers” are in fact true positives, accurately reflecting underlying clinical disease.  In this retrospective cohort of 153 elderly patients for whom a urine culture was sent along with a urinalysis, nearly half of urinalyses were false positives.  Adding in the not-insignificant incidence of non-pathogenic asymptomatic bacteriuria, some of these positive culture results were likely false positives as well.  The authors of this article feel this reflects substantial overdiagnosis and overtreatment.

This assertion is almost certainly correct.  However, these authors are short of suggestions regarding the improvement of diagnostic accuracy.  They suggest, perhaps, urine samples ought only be taken by catheter, and treatment be initiated only on positive culture results.  However, more practical and expedient diagnostic methods are lacking.

“Overtreatment of Presumed Urinary Tract Infection in Older Women Presenting to the Emergency Department”
www.ncbi.nlm.nih.gov/pubmed/23590846‎