Appendicitis Continuing debate about treatment

The other day on Twitter, Kenny Goldberg (@kghealth), a health reporter at KPBS News in San Diego, asked me, "Why all the stories on antibiotics vs. surgery for appendicitis? Are appendectomies inherently dangerous?" My answer was "Great question. The answer is a resounding No. The complication rate is very low."

Yet the papers keep coming.

A new systematic review of all the randomized controlled studies on appendicitis found important shortcomings in all of them. Here are a few:

Bias in selecting patients was a problem in all six of the studies reviewed. Diagnostic criteria for inclusion in the studies were not standardized. Some of the studies enrolled patients with clinically diagnosed appendicitis only. Since some patients may not have had appendicitis, they would probably have improved regardless of how they were treated.

Patients were treated with a variety of antibiotics, Since most of the studies were done in Europe, open appendectomy was the more common surgical intervention. Laparoscopic appendectomy results in fewer complications and shorter lengths of stay than the traditional open procedure.

Follow-up in five of the six studies was one year with only one study following patients as long as a median of 17 months. Rates of recurrent appendicitis necessitating appendectomy ranged from 24% to 60% with an average of 35.4%. What will the recurrence rates be at 3 years? 5 years?

The authors concluded that although more evidence for treating appendicitis with antibiotics has emerged, the comparative effectiveness of that strategy is still unknown. They recommend that patients should be enrolled in clinical trials or registries to help answer this therapeutic question.

The second recent paper involves two issues I have commented about many times—research and medical reporting.

Its a study of 102 pediatric patients between the ages of 7 and 17 with uncomplicated appendicitis as judged by CT scan parameters. After informed consent was discussed, parents were permitted to choose the therapeutic arm, antibiotics or laparoscopic surgery.

Of the 629 patients who presented with acute appendicitis during the study period, only 102 (21%) met the studys inclusion criteria of whom 37 were selected for antibiotic therapy by their parents.

During the median follow-up period of 21 months, 9 (24.3%) patients initially treated with antibiotics had to undergo appendectomy.

I blogged about this studys preliminary results when they were published back in 2014. If you would like more details about its limitations, read that post.

The inadequacies of medical reporting on this paper were rather glaring. Under the headline "Not all kids with appendicitis need surgery. Antibiotics can work just fine," the Boston Globes new website Stat News said the following:

“Their parents began to question whether they needed surgery [for appendicitis], said [lead author] Dr. Peter Minneci, a pediatric surgeon at Nationwide in Columbus, Ohio. Minneci decided to answer the question with a controlled study." Sorry folks, this wasnt a controlled study.

The New York Times reported: "The surgery group had more complications and two of those who chose antibiotics had to be readmitted to the hospital for appendectomies in the first 30 days." This is misleading because although 5 of 65 patients in the surgery group had postoperative complications compared to none of the 9 who eventually had appendectomies in the antibiotic group, the difference was not statistically significant (p = 1.0, Fishers exact test).

But the most interesting thing about this paper was an entire page explaining why allowing parents to select the therapy was a better method than randomizing patients to one group or the other. Its very clever and must be read to be appreciated.

Here is an excerpt: "The patient choice design allows a therapy to be aligned with the preferences of the patient and his or her family, thereby minimizing the potential negative effects of preferences."

I dont know about you, but if I or anyone in my family had appendicitis, my preference would be for a laparoscopic appendectomy.

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Hospitals Mess Up Medications in Surgery—a Lot

Yes, that was the inflammatory headline on Bloomberg Business News last week. It is great click-bait, but factually off base because the research it refers to was done at only one hospital.

Heres what the study found. During 277 operations with 3,671 medication administrations observed at the Massachusetts General Hospital, 193 (5.3%) involved a medication error or an adverse drug event. One or more errors or adverse drug events occurred in 124 (44.8%) of the procedures.

In all, 40 (20.7%) adverse drug events were not preventable—for instance, an allergic reaction to a drug that was not known about before. Of the remainder, “32 (20.9%) of the errors had little potential for harm, 51 (33.3%) led to an observed adverse drug event and an additional 70 (45.8%) had the potential [emphasis added] for patient harm."

Sounds bad, but the Bloomberg article goes on to say "While all the errors observed in the study had the potential to cause harm, only three were considered [potentially] life-threatening, and no patients died because of the mistakes. In some cases, the harm lay in a change in vital signs or an elevated risk of infection."

The hospitals own press release, published on the science website EurekAlert, said this: "The most frequently observed errors were mistakes in labeling, incorrect dosage, neglecting to treat a problem indicated by the patients vital signs, and documentation errors."

Mistakes in labeling syringes, occurring 24.2% of the time, were the most common type of error despite the presence of a bar code-assisted labeling system. This begs the question, how valuable is a bar code system that only prevents problems 75% of the time?

A website called FierceHealthcare took it up a notch saying, "While the research was conducted on procedures that took place at MGH, it indicates that similar failures happen at hospitals around the country."

It indicates no such thing. The paper actually says "our findings may not be generalizable to nonteaching hospitals." Or as is the case with most papers from a single institution, the results may not be generalizable to any other hospital.

Finally, the lead author of the study poured more gasoline on the fire with this comment, "Patients don’t need to go into surgery thinking that they’re going to have lasting permanent harm every second operation."

The study found nothing to suggest that 50% of patients suffered "lasting permanent harm." In fact, it isnt clear that any patients suffered lasting permanent harm, and most (66.7%) of the medication errors and adverse drug events were only potentially harmful.

Google “medication errors” and click on “News” for links to several more hand-wringing reports about the MGH study.

Although the paper and its accompanying media blitz may have overstated the severity of the problem, too many potentially harmful errors are occurring in the operating room and anesthesiologists need to clean up their act.

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