Sunday, 21 February 2021

Compression Therapy to Prevent Recurrent Cellulitis of the Leg… way to go Bruce!


We’ve all seen them…

Those big red chronic oedematous legs that we diagnose as cellulitis. We start IV antibiotics and admit. But those same legs come back to the ED again and again…

Hummm... should we be doing something to prevent recurrent cellulitis in oedematous legs?

These investigators from the Public Hospital Bruce, Canberra, conducted a single centre non-blinded RCT of patients with chronic oedema of the leg and recurrent cellulitis. Participants were randomised to leg compression therapy vs. control.

The primary outcome was recurrence of cellulitis as diagnosed by GP’s or hospital physicians and confirmed by trial assessors. There were a bunch of secondary outcomes including measuring leg volume with the use of a perometer (huh?), quality of life, adherence to intervention etc.

Shortly after starting the trial, lymphoedema therapists who were aware of the group assignments noticed a potential large treatment effect and brought it to the attention of the Human Research Ethics Committee (HREC). Stopping rules were added to the study protocol. As expected, the trial was stopped early for efficacy.

In the end, 84 patients were enrolled with 23 episodes of recurrent cellulitis. There were 6 (15%) patients with cellulitis in the compression group and 17 (40%) in the control arm.

Wow… an absolute reduction of 25% or NNT of 4. This is crazy efficacy.

(Just in case you were curious, the perometer showed a between group difference of -240ml in leg volume over time.)

Critics of this trial could justifiably point out that it was really small, stopped early, and conducted at single centre.  But perhaps the biggest limitation was the diagnosis of recurrent cellulitis is subjective and it was adjudicated by those who were unblinded- potentially leading to bias.

Either way, these results are very compelling, in line with expert opinion and should be practice changing. As ED doctors, we don’t usually focus on preventative medicine. But this intervention will have much more effect than those countless tetanus immunisations we give away.

Looks like it’s time to get on the compression train.


Covering:

Compression Therapy to Prevent Recurrent Cellulitis of the Leg. N Engl J Med. 2020;383:630-9. [link to article]

Saturday, 20 February 2021

Short-Term Topical Tetracaine is Highly Efficacious for the Treatment of Pain Caused by Corneal Abrasions: A double-blind RCT


It seems to me that these researchers asked the wrong question. Most of us know that numbing up a corneal abrasion relieves pain. But the big question has always been is it safe to send patients home with topical anaesthetic. For decades, ophthalmologist have been telling us it is dangerous.  But lately, this dogma has been challenged with better quality research.

So if they didn't ask the right questions, then why was this study conducted and published in our peak emergency medicine journal?

It turns out we have never proven the efficacy of topical anaesthetics for outpatient treatment of simple corneal abrasions with an RCT. Go figure...

But, now we have.

This well conducted RCT out of a single ED in Oklahoma (yeeeehaaaaaaa!) randomised 111 patients to 2ml’s of tetracaine drops vs placebo to take home. The primary outcome was the overall NRS pain score at a 24-hour and 48-hour ED follow-up.

As expected, the tetracaine worked marvellously. Pain score was 1/10 in the tetracaine group and 8/10 in the placebo group. This is a huge difference with lots of pretty p values. The placebo group also gulped down more Vicodin than the those given tetracaine (don’t get me started…)

Unfortunately, we cannot make claims about safety with so few trial participants. A much larger study will be needed to find less common side effects. But the original studies that suggested harm are old and poor quality. It seems that the current best evidence suggests topical anaesthetics are probably safe and definitely effective for simple corneal abrasions.

But don’t be surprised if your local ophthalmologists disagree… it's hard to teach an old dog(ma) new tricks. 

 

Covering:

Shipman S, Painter K, Keuchel M, et al. Short-Term Tetracaine is Highly Efficacious for the Treatment of Pain Caused by Corneal Abrasions: A Double-Blind, Randomized Clinical Trial. Ann Emerg Med. 2020 Oct 27;S0196-0644(20)30739-3.    doi: 10.1016/j.annemergmed.2020.08.036 [link to article]

 

 

Thursday, 18 February 2021

Early Rhythm-Control Therapy in Patients with Atrial Fibrillation

Rate vs. rhythm control of atrial fibrillation has been a perennial question.


These investigators sough to determine if patients with “early atrial fibrillation” (<1 year since diagnosis) and cardiovascular conditions had better outcomes with rhythm control.

The was a behemoth study and worthy of publication in the NEJM.

2789 patients in 135 centres in 11 different countries in Europe were randomised to either rhythm control (antiarrhythmic drugs, ablation, & cardioversion) vs. usual care (mostly rate control but occasionally rhythm control to manage AF related symptoms.)

One primary outcome was a composite of death from cardiovascular cause, hospitalisation for heart failure and/or ACS. The other primary outcome was nights spent in hospital. There were lots of secondary and safety outcomes.

After a median 5 year per patient follow up time, the trial was stopped early due to efficacy at the 3rd interim analysis. There was an absolute decrease of 1.1 events per 100 person years for the first primary outcome. This may not seem like much of a treatment effect, but there are a lot of people out there with AF.

No study is perfect, and this one has some limitations. There were reasonably narrow inclusion criteria which limit generalisability. It probably excluded most symptomatic patients as they would not have been candidates to be randomised to “usual care.” In the manuscript, there is an entire column of author conflicts of interest- in small font no less! Cardiologist love to cosy up to industry….

Either way, this study will change the guidelines. And in speaking with my local electrophysiologist, this study has already changed practice. Cardiologists are pushing suitable patients with new AF towards a rhythm control strategy with antiarrhythmics and more ablations are being performed.

Of course, emergency physicians are not likely to prescribe antiarrhymics and certainly won’t do ablations (unless you want a friendly visit from a regulatory body). But it is good for us to know the overall strategy and we will be asked to be more aggressive with early rhythm control.


Covering:

Kirchhof P, Camm AJ, Goette A, et al. Early Rhythm-Control Therapy in Patients with Atrial Fibrillation. N Engl J Med. 2020;383:1305-16. [link to article]

Testicular Workup for Ischemia and Suspected Torsion in Pediatric Patients and Resource Utilisation: Everybody do the TWIST?

 


The TWIST score is a "validated" clinical decision instrument to aid in the diagnosis of acute testicular torsion.

TWIST sore?

Yes, I’ve never heard of it either… and I will probably forget about it very soon.

The TWIST score (0-7) is calculated by the presence of testicular swelling (2 points), hard testes (2 points), nausea/vomiting (1 point), high riding testes (1 point), and absent cremasteric reflex (1 point). Based on the score, patients can be stratified into high, intermediate, or low risk. I’ll spare you further details…

These authors sought to apply the TWIST score to a group of patients by performing a retrospective medical record review. They were looking at potentially decreasing formal ultrasound use, decreasing ED length of stay and ischemic time. (Methods for their chart review are absent however…)

Results?

77 patients were identified by ICD-10 codes. All 9 high risk patients had torsion. And it was absent in the 57 low risk patients. The authors claim the score could have reduced the need for ultrasound 75% of the time and reduced ischemia time.

Sounds great, but there are major problems with this study.

Retrospectively collected data is usually poor quality. The authors assumed data not recorded indicated absence of findings. Of course, this is nuts (sorry).

Regardless of prior studies, I don’t believe the TWIST score has face validity. The most important features in diagnosis of torsion are the appropriate age (usually adolescent) and the history. Sudden severe pain with vomiting and potentially a high-riding testicle is all you need. These patients should not be getting ultrasounds… just an immediate referral to the appropriate surgeon. A hard & swollen testicle is very common in orchitis and I can’t believe it wound be discriminatory. 

Of course, a clinical decision instrument should improve upon what we do already. These scores must be compared to clinician gestalt before being adopted. Otherwise we don’t know if they will underperform and cause harm.

Regardless of what Cubby Checker says, please don’t do the TWIST.

 

Covering:

Roberts CE, Ricks WA, Roy JD, et al. Testicular Workup for Ischemia and Suspected Torsion in Pediatric Patients and Resourse Utilization. J Surg Res. 2021;257:406-411. [link to article]

Thursday, 5 November 2020

Lunacy in a tertiary ED: A study of the association between moon cycles and violence


Of course, we have all heard the full moon makes people barking mad and creates chaos in the ED.

“It must be a full moon!”

This study out of Melbourne looked at ED patient records over 3 years and compared the rate of “occupational violence and aggression” with the lunar cycle divided into quarters; new moon, first quarter, full moon and third quarter. Then they performed logistic regression to determine the association between the cycle and rates of violence.

In the end, they had 184,059 patients who presented to the ED over three years. It turns out that violence and aggression was NOT associated with a full moon but it was statistically associated with the first quarter (adjusted OR 1.38; P<0.01) and the third quarter (adjusted OR 1.29, P=0.03).

Well, there you have it…

In the discussion, the authors provide physiologic justification for the observed association based on some brilliant quotes from “prominent astrologers Dana Gerhardt and Dane Rudhyar.”

But the rational side of us knows this is completely nuts… just as we know that the transit of Venus doesn’t cause urinary retention and a meteor shower doesn’t cure syphilis.

This article appeared in Emergency Medicine Australasia. It did not appear in a predatory journal or the Christmas edition of BMJ. It was delivered in “dead pan” without even a hint of a wink at the end.

But the authors knew exactly what they were doing. And it provides us with a couple of valuable lessons.

Statistics can get things wrong.

I’m sure if the authors looked at the association of astrological birth signs (i.e. ISIS-2) with violence they would have found some statistically significant results; Capricorn and Leo were hot heads, but Gemini calm as a cucumber.

We need to be reasonably skeptical of the medical literature. Much of what gets published turns out to be false

Thanks to these authors for getting it right… wink… wink…

 

Covering:

Teung T, O’Reilly G, Mitra B, Olaussen A. Lunacy in a tertiary emergency department: A 3 year cohort study of the association between moon cycles and occupational violence and aggression. Emerg Med Aus. https://doi.org/10.1111/1742-6723.13601

 

 

  

Wednesday, 4 November 2020

Comparison of oral ibuprofen and acetaminophen with either analgesic alone for pediatric patients with acute pain. A crash landing...


You would think we should know the answer to this question already. But officially we don’t, and this paper adds absolutely nothing to our understanding.

This single-centre randomised, double-blind trial compared the analgesic efficacy of a combination of ibuprofen (10mg/kg) plus acetaminophen (15mg/kg) to either medication alone for the treatment of mostly acute traumatic pain in children. 

The primary outcome was pain scores at 60 minutes.

They concluded that the reduction in pain scores was similar between all groups. No difference...

The study design was quite good. But like a plane with no wings, there was a fatal flaw.

They only included 30 patients in each treatment arm!!!

Huh?

They provided a crazy power calculation, but it clearly does not pass the sniff test.

30 patients would have only enough power to find large changes in treatment effect making this at high risk for a type II error- or a false negative study. (A quick check of Clinicatrials.gov shows the study was originally intended to enrol 125 patients in each arm.)

I’m surprised the ethics committee approved such a study as it could never adequately answer the research question it proposed. I’m also surprised it got published, albeit in a lesser impact factor journal.

I strongly suspect the peer reviewers snuck the last sentence in to the abstract, “…but the trial was underpowered to demonstrate the analgesic superiority of the combination of oral ibuprofen plus acetaminophen in comparison with each analgesic alone.”

If this was the case, then why was the study conducted?

 

Covering

Motov S, Butt M, Masoudi A, et al. Comparison of oral ibuprofen and acetaminophen with either analgesic alone for pediatric emergency department patients with acute pain. J Emerg Med. 2020;58:725-732.[Link to article]

Monday, 2 November 2020

An RCT comparing antibiotics vs. surgery for appendicitis- the CODA trial


This is a big deal… the largest RCT comparing antibiotics vs. surgery for appendicitis and has closed the lid on this research question.

This non-blinded, pragmatic trial included adults with mostly image proven appendicitis in 25 centers in the USA. They excluded sick patients with shock, diffuse peritonitis, severe phlegmon, free air (microperforations were ok), neoplasm a few other things.

The antibiotic group got IV for 24 hours followed by oral tablets for 10 days.

The primary outcome was an overall health questionnaire at 30 days. Secondary outcomes were rate of appendicectomy in the antibiotic arm, complications, return to work etc.

The decision to perform appendicectomy in the antibiotic arm was up to the treating clinician.

Results?

1552 patients were enrolled from May 2016 to February 2020.

Antibiotics were non-inferior to appendectomy based on the 30-day health status. In the antibiotic group, 29% underwent appendicectomy by 90 days. (Those with appendicoliths were more likely to eventually get surgery). Half of the patients randomized to antibiotics were discharged from the Emergency Department!

I would imagine that the rate of appendicectomy could have been lower in this study given it was unblinded… the surgeons struggling to put their scalpels down after decades of surgical dogma.

Of course, this is not the first RCT’s looking at antibiotics for appendicitis. The message is consistent and it is clear where we stand. Antibiotics successfully treat acute uncomplicated appendicitis, but a small percentage (30-40%) of patients eventually get their appendix out.

It is now evident that we need to present patients with treatment options for appendicitis in a shared decision-making process

Yes, old habits die hard. But kneejerk surgery for appendicitis is now a stinking corpse.

 

Covering:

Flum DR, Davidson GH, Monsell Se, et al. A Randomized Trial Comparing Antibiotics with Appendectomy for Appendicitis. N Engl J Med. 2020 Oct 5. doi: 10.1056/NEJMoa2014320. Epub ahead of print. PMID: 33017106. [link to article]