Friday, December 7, 2018

A fatal medication error

A 75-year-old woman died at Vanderbilt University Medical Center after receiving intravenous vecuronium, a drug that causes muscle paralysis, instead of Versed, a sedative.

Here’s what happened.

She had been recovering well from an intraparenchymal brain hematoma after a fall. While awaiting a full body positron emission tomography (PET) scan in the radiology department, the patient said she was anxious about being in the machine because she was claustrophobic.

A doctor ordered Versed 2 mg IV in the electronic medical record at 2:47 PM. Two minutes later, the pharmacy verified the order. The radiology department staff said they could not give the medication because they were very busy and the patient would need to be monitored.

So nurse A, who was functioning as the “help all” nurse was asked by the patient’s nurse, nurse B, to go to radiology and give the medication. At 2:59 PM, nurse A went to the automated dispensing cabinet (ADC) and searched for Versed in the patient’s profile. When she couldn’t find the drug listed, she selected the “override” setting to search for the drug. She entered the first two letters of the drug, VE, and clicked on the first medication that popped up.

Wednesday, November 28, 2018

Can you be held liable for resuscitating a patient who has a DNR order?

A New Mexico woman, suffering from Dercum’s disease (adiposis dolorosa) which causes painful fatty tumors, is suing a Santa Fe hospital and an emergency physician claiming she was the victim of two negligent acts in 2016.

One, according to the Albuquerque Journal, she told hospital personnel she was allergic to Dilaudid but went into cardiac arrest after receiving an injection of the drug.

Two, despite the presence of a lawfully executed “do not resuscitate” (DNR) advance directive, she was successfully resuscitated and now faces continued pain and medical bills.

The staff had been aware of her DNR order and had even issued her a purple bracelet labeled “DNR.” However since the cardiac arrest was allegedly caused by an allergic reaction to Dilaudid, the staff may have felt her problem was not related to her illness and would likely result in a successful resuscitation.

While researching this subject, I found several instances of patients or families suing hospitals and doctors for failing to heed a DNR order or what some have called “wrongful life.”

However, I found only one major case that had gone to conclusion. A Georgia woman had both an advance directive and a healthcare proxy—her granddaughter. She was admitted to a hospital for a cough and eventually required a thoracentesis. The healthcare proxy agreed to allow the procedure to be done but specifically said her grandmother did not want intubation or mechanical ventilation.

A 2017 paper in The Journal of Clinical Ethics said the patient was temporarily intubated and ventilated during the thoracentesis. She was extubated, but a bout of respiratory distress was treated with intubation and mechanical ventilation again without consulting the granddaughter. The patient died two weeks later.

The granddaughter sued, and the hospital settled for $1,000,000. I believe this is the first such case settled for that much money. The biggest problem was failure of the doctor to communicate with the healthcare proxy.

Many issues in medicine are not black or white. Here’s the other side of the story. An elderly Boston man suffered a cardiac arrest in a hospital CT scanner and was resuscitated. The resident who treated him wrote that during the code, a nurse discovered a 6-year-old advance directive saying he did not want to be resuscitated in his chart.

But the code team noted he had walked into the hospital for the test and felt certain they could save him. They contacted his son and healthcare proxy who said “My father would want everything done to save his life.” The code was successful. He was weaned from mechanical ventilation and extubated after a few hours. He thanked his doctor and was discharged from the hospital two days later.

Some take-home points:

A DNR order and an advance directive may not necessarily be the same. For more information, read an interview with the plaintiff’s lawyer in the Georgia case.

Whether to resuscitate a patient or not may depend on the circumstances [e.g., whether an event is likely reversible or not], the wording of an advance directive, and/or the wishes of the healthcare proxy.

If possible, explain the possible scenarios and outcomes of resuscitation and DNR to your patients and their families well before a cardiac arrest occurs.

Communicate with patients and their healthcare proxies.

Thursday, November 1, 2018

Appendectomy outcomes in the modern era

Finally we have some data on the current rate of complications of appendectomy for uncomplicated appendicitis. But that’s not all. This new paper, published online in the journal Surgery, reveals much about the diagnosis, technique, and outcomes of appendectomy in the United States.

Using data from 115 hospitals participating in the National Surgical Quality Improvement Program, researchers at UCLA analyzed the results of 7778 adult patients undergoing appendectomy for simple appendicitis in 2016.

Thursday, October 4, 2018

A Venezuelan surgical resident appeals for help

I received the following email. It has been edited for length and readability.

I assume you know is happening in my country, Venezuela. Basically a communist-socialist party has taken control of the government for 20 years now and has the citizens under the worst economic crisis of South America along with one of the most important refugee situations of the continent.

I can write 300 pages about it, but I believe I’ve said enough. As you may know, EVERYTHING has gone to bad situations in this country: public services, roads, HOSPITALS, UNIVERSITIES, food shortage, lack of water and electricity, freedom of speech, and the list goes on and on.

Tuesday, October 2, 2018

A Revolutionary Experience!


Listen as renowned surgeon Leo Gordon reads his epic story about pancreatic insufficiency and the American Revolution. Based on a true story. The podcast is 15 minutes long and worth every second of it.

Wednesday, September 19, 2018

“Number of medical students pursuing surgery specialty drops by half”


That was the headline in a September 10 Becker’s ACS Review article. The first sentence of the piece was more specific, “Only 4 percent of medical students surveyed in 2018 said their chosen medical specialty is general surgery, compared with 8 percent in 2016, according to Medscape's Medical Student Life & Education Report 2018.”

This caused some consternation among general surgeons on Twitter. I tweeted, “Interesting. Lifestyle is finally catching up to us. I think it will get worse.”

Thursday, September 6, 2018

How to interpret the literature: A new series of posts

The Salty Statistician will be a recurring feature of this blog wherein we ask statisticians in medicine to break down articles from the surgery literature and assess whether the reported conclusions are supported by the data. Let’s look at this study:

Groh MA et al. Is Surgical Intervention the Optimal Therapy for the Treatment of Aortic Valve Stenosis for Patients With Intermediate Society of Thoracic Surgeons Risk Score? Annals of Thoracic Surgery.

The authors attempted to address the question of whether aortic stenosis patients deemed “intermediate risk” [IR] for surgical aortic valve replacement [AVR] are best treated with open surgery or transcatheter AVR. The authors looked at 1,144 patients who received surgical AVR from 2008-2014 at a single center focusing on the 620 “intermediate risk” patients. At the end of the follow-up period, 72 had died.

Unfortunately, major methodological issues undermine the paper’s conclusions. Fortunately, this provides an excellent teaching opportunity.

First, the authors inappropriately used logistic regression to analyze independent predictors of mortality. Logistic regression treats the outcome as a simple “Yes” or “No” variable, while ignoring the time-at-risk. This study included patients treated over a six-year period (2008-2014) who therefore have substantial differences in the amount of time at risk. Consider the following hypothetical patients.

Patient A treated in 2008 and died in 2014 surviving six years after surgery. The logistic regression model simply counts patient A as “dead.”

Patient B treated in 2014 and alive in 2017 but dies in 2018, after the data were analyzed and the paper published. He survived four years after surgery and in the logistic regression model, counts as “alive” since data were analyzed in 2017.

Patient A lived for six years after surgery, but counts as “worse” in the analysis than Patient B who only lived for four years because of the time at which the data were “frozen” and analyzed. Of course, this is unavoidable in long-term outcomes studies, but one must choose an appropriate statistical method that accounts for time-at-risk.

Cox proportional-hazards models are more appropriate for a long-term survival outcome than logistic regression. When building a Cox model, one specifies both the current status (i.e., alive/dead) as well as an amount of follow-up time. For example, Patient A is “dead” with six years of follow-up; Patient B is “alive” but with only three years of follow-up. This provides a proper assessment of how strongly the independent variables are associated with risk of mortality while accounting for the unequal follow-up time.

Second, the authors state their data supports the conclusion that “SAVR is the optimal therapy for most of the patients” in the IR group in comparison to TAVR. However, their paper lacks any data on outcomes in IR patients who were treated with TAVR. Why the authors believe presenting data from a series of SAVR patients is sufficient to claim that SAVR is the “optimal therapy” absent any comparison data on patients treated with TAVR is unclear. Randomized controlled trials have more appropriately compared SAVR and TAVR in the IR population. Link here and here.

Which patients should receive surgical AVR versus transcatheter AVR is a good question, but to answer it, the paper used an incorrect approach.

Final Rating (1-5 Scalpels): 1 Scalpel - significant methodological issues

This issue of the Salty Statistician was written by Andrew Althouse (@ADAlthousePhD), currently an Assistant Professor of Medicine at the University of Pittsburgh as well as Statistical Editor of Circulation: Cardiovascular Interventions.

We intend this series to focus on work that is perceived to have a high impact on clinical practice, so we welcome reader suggestions. If you have a paper that you would like to see reviewed as part of the Salty Statistician series, please tweet @Skepticscalpel or @ADAlthousePhD or email SkepticalScalpel@Hotmail.com. We cannot promise that all submissions will be reviewed in this space, but we will do our best.