Friday, March 16, 2012

Pharmaceutical Bias Article in EM News

Imagine my surprise to be paging through Emergency Medicine News this month and stumble upon an article about TPA in stroke - and find that it's a review of my Western Journal of Emergency Medicine article from last summer.

The EM News article is here:
http://journals.lww.com/em-news/Fulltext/2012/03000/Journal_Scan__Pharma_Bias_Detected_in_Thrombolytic.6.aspx

And my West JEM article is open access, available here:
http://escholarship.org/uc/item/9504g8md

It Feels Good To Use an iPad

Recently, there has been a great deal of coverage on internet news sites with headlines such as "Study: iPads Increase Residency Efficency."  These headlines are pulled from a "Research Letter" in Archives of Internal Medicine, reporting from the University of Chicago, regarding the distribution of iPads capable of running Epic via Citrix.

Sounds good, but it's untrue.

What is true is that residents reported that they used the iPads for work.  The additionally thought that it saved them time, and thought it improved their efficiency on the wards.  This is to say, they liked using the iPad.

The part that isn't true is where the authors claim an increase in "actual resident efficiency."  By analyzing the hour of the day in which orders are placed, the authors attempt to extrapolate to a hypothetical reality in which this means iPads are helping their residents place orders more quickly on admitted patients, and to place additional orders while post-call, just before leaving the hospital.  There is, in fact, no specific data that using the iPad makes the residents more efficient, only data showing the hour of the day in which orders are placed has changed from one year to the next.  The iPad has, perhaps, changed their work habits - but without prospectively observing how these iPads are being used, it is impossible to conclude how or why.

But, at least they liked them!  And, considering how addictive Angry Birds is, I'm surprised their productivity isn't decreased.


"Impact of Mobile Tablet Computers on Internal Medicine Resident Efficiency"

http://archinte.ama-assn.org/cgi/content/extract/172/5/436

Wednesday, March 14, 2012

Ketamine + Propofol = Ketofol

Combining propofol, a beloved agent for procedural sedation for its rapid onset, quick recovery times, and titratable levels of sedation with ketamine, the world's safest agent for unmonitored anesthesia, has been shown in case series to be as safe and effective as expected.

This small, randomized trial is a direct comparison between ketofol and propofol, with the primary outcome measure being the proportion of patients experiencing an adverse respiratory event using the standardized Quebec Criteria.  The authors are testing the hypothesis that use of ketofol will result in fewer adverse respiratory events, which they believe to be one of the weaknesses of propofol, and one of the strengths of ketamine.

With ~120 patients in each group, there is essentially no clinical or statistical difference between outcomes of the two groups.  Clinicians provided transient assisted ventilation for three ketofol patients and one propofol patient - which is not statistically different.  Secondary outcomes were similar, although a handful of ketofol patients experienced recovery agitation, some of which required treatment.

It seems odd to me that the authors would be testing the respiratory adverse events of ketofol - both ketamine and propofol are so profoundly safe, with already extremely low rates of assisted ventilation, and unplanned intubation rates of ~1 in 5,000 or more.  Ketofol has been similarly already shown to be extremely safe in terms of respiratory events, primarily in retrospective case series.  They've essentially set themselves up to test something that's almost already conclusively expected to generate insignificant differences.  What is more interesting to clinicians now, when considering agents for sedation, is the secondary effects - hypotension, hypersalivation, vomiting, myoclonus, agitation - and how that affects procedural success and time to disposition.  Ketofol is a great combination - but its value seems to be in the mitigation of the non-airway adverse events.

"Ketamine-Propofol Combination (Ketofol) Versus Propofol Alone for Emergency Department Procedural Sedation and Analgesia:  A Randomized Double-Blind Trial"
http://www.ncbi.nlm.nih.gov/pubmed/22401952

Monday, March 12, 2012

Mechanical Thrombectomy - Promising, But Still Unsafe

This article is just a retrospective, consecutive case series from Spain reporting outcomes and adverse events from mechanical thrombectomy in acute stroke.  Most of their patients are significantly disabled from their strokes, with NIHSS ranging from 12 to 20 - unlikely to have great outcomes - but 14% developed intraparenchymal hemorrhage and 25% were deceased at 90 days.  Six patients had vessel wall perforation from the thrombectomy device.

The key sentence is the last sentence:
"Clinical efficacy of this approach compared with standard medical therapy remains to be demonstrated in prospective, randomized controlled trials."

When mortality is 25% here, and 33% at 90 days in MERCI, multi-MERCI, and Penumbra trials, I'm still not sure this strategy is quite ready for prime time.  They do report that 54% had a "good outcome", but it's interesting to see that "good outcome" in stroke trials has progressed from Rankin Scores of 0 or 1 in NINDS etc. to ≤2 in these new trials.  They  also don't offer a lot of granularity in their outcomes data.

But, as usual, as long as there are authors out there who "receive consulting and speaker fees from Co-Axia, ev3, Concentric Medical, and Micrus," we'll keep seeing reports like this.

"Manual Aspiration Thrombectomy : Adjunctive Endovascular Recanalization Technique in Acute Stroke Interventions"
http://www.ncbi.nlm.nih.gov/pubmed/22382156