Monday, December 14, 2015

Appendicitis and shared decision-making

Staying with the current theme of appendicitis on my blog, here is a summary of recent developments. A JAMA Surgery Viewpoint suggested that because of the findings of a Finnish randomized trial, surgeons now should give patients with appendicitis a choice between an appendectomy or treatment with antibiotics.

The paper acknowledged my criticisms of the Finnish study which found that simple appendicitis could be treated successfully with antibiotics in almost 75% of patients.

I respect the authors of the JAMA Surgery article and am happy they referenced the blog post noting my concerns about that Finnish trial: the trial compared antibiotics to open appendectomy—an operation with more complications than the more commonly performed laparoscopic appendectomy; the antibiotic used in the Finnish trial is not a first line choice in the United States; patients were followed for only one year.

The JAMA surgery paper answered three questions I posed in a previous post. One, the Viewpoint authors consider antibiotic therapy for appendicitis mainstream. Two, surgeons must assume that patients might opt for antibiotics despite at least a 25-30% chance of suffering a recurrence of appendicitis. Three, an informed consent discussion now should include a mention of antibiotics as an option.

I disagree with the Viewpoint authors’ assertion that antibiotics are as safe and effective as surgery for treating appendicitis. Based on one flawed study, antibiotic therapy cannot yet compare to the many years of excellent results of laparoscopic appendectomy.

Here are some other problems.

Let’s talk about shared decision-making. After hearing all the options, some patients will want to guide their own care. However, most patients would rather not. A 2011 Journal of Medical Ethics study of over 8000 patients found that 97% “of respondents wanted doctors to offer them choices and to consider their opinions. However, two out of three (67%) preferred to leave medical decisions to the doctor.”

What about the medicolegal implications of antibiotic therapy for appendicitis? Right now, the “standard of care” for appendicitis is appendectomy. Suppose a surgeon, in the interest of shared decision-making, explains the Finnish study to a patient and neglects to mention that it only involved patients with simple appendicitis. Or suppose that patient’s CT scan is read as simple appendicitis but is not accurate, and the patient actually had complicated appendicitis that went on to perforate despite antibiotic therapy.

If that patient becomes septic and requires a laparotomy and suffers a subsequent wound infection and massive hernia or dies, who is going to be held responsible for not recommending an appendectomy? Certainly not the patient.

In the era of shared decision-making and patient autonomy, maybe patients should be required to carry malpractice insurance so they can sue themselves if the decisions they make turn out badly.

24 comments:

E said...

I do mention antibiotics to my patients as an option, but in a biased way. ("Some studies suggest that appendicitis can be treated with antibiotics alone. My bias as a surgeon is that I can make you better, get you out of the hospital in less that 24 hours, and remove your risk of future episodes of appendicitis with a laparoscopic operation") I'm not convinced by the evidence, and I'm unwilling to suggest that I am to patients. I do bring it up at this point, and allow the patient to continue the conversation if they desire. Most of the time, they want to get to the OR.

Skeptical Scalpel said...

E, sounds good to me.

Chris said...

I am not a lawyer--but I think documentation should play a big role in assignation of liability related to these discussions.

For example, it seems to me it would be perfectly reasonable from both the empowered patient's and the surgeon's perspective for the surgeon to offer the options, and then make their recommendation: "antibiotics have been tried with success in some cases; my experience has been that surgery is better and that's what I recommend." The patient is then free to be empowered to whatever extent they choose, and can say either "whatever you say doc" or "I still don't want surgery."

If such a conversation actually takes place and is appropriately documented (with a signed informed consent, for instance) it seems to me that the patient should assume the liability for their "empowered decision", provided of course that subsequent errors do not lead to a bad outcome, such as "missing" a perforation and then sending them home with rebound tenderness and vomiting.

I'm sure a plaintiff's attorney would disagree, though.

Skeptical Scalpel said...

Chris, I agree in principle with what you said. However, the fallback position for patients/plaintiffs regarding informed consent is "I heard what the doctor said, but I didn't really understand it."

Most suits are based on bad outcomes and not the nuances of what was said or not said in an informed consent discussion.

Chris said...

Reliance on flawed epistemic claims could be fixed with malpractice reform (probably).

If patients want empowerment--and they should--they should also have to share some of the responsibility for the outcomes of that SHARED decision-making.

In 2015, it's not as though you could force the patient who wanted antibiotics to undergo appendectomy against their wishes; you'd be charged with assault.

Skeptical Scalpel said...

Even before 2015 you couldn't force a patient to have an operation. I have always believed that informed consent is impossible in some patients. There are those who simply cannot understand the implications of some of the possible adverse outcomes. Some plaintiffs have claimed that although they heard the list of possible complications, they did not really understand what was being said.

Chris said...

I don't think you're wrong, but that reflects a fundamental flaw in the entire concept of informed consent and patient empowerment. And criticism of patient empowerment is not generally popular...

Skeptical Scalpel said...

It's not PC. I've taken heat for comments like this before. http://skepticalscalpel.blogspot.com/2011/08/more-on-patients-and-shared-decision.html

Justin said...

Are you obligated to bring up alternatives that are dumb?

artiger said...

I do it the way E mentioned in the first comment, and I don't see anything wrong with it. Part of what patients supposedly want from us is our opinion and experience, not just technical ability. So if we are biased due to our experience with surgical cures, or can look at a flawed study and call a spade a spade, or know the dangers of prolonged and possibly repeated antibiotic exposure, etc., I don't see a problem with being truthful. Don't ask to see a surgeon if you don't want an operation.

I have yet to have a patient request the antibiotic route. My patients might not be very bright, but they understand that 75%<100%.

Anonymous said...

From a strictly selfish point of view I hope, eventually, the ED physician will explain it all to the patient and call me only if the patient wants an appendectomy. Otherwise admit to the family doctor.

HaHa only in my dreams!

Skeptical Scalpel said...

Justin, I don't think so but I'm not a lawyer or a jury.

Artiger, great points.

Anon, I had brought up the issue of who will discuss this with the patient in a previous post. How would you like to go in to see a patient at 10 pm and then have him opt for antibiotics? Not a problem if you have residents, but in a non-teaching hospital--big problem.

artiger said...

Scalpel, to be fair, even down here in the sticks (without residents, I might add), if I get a call for such a patient at 10pm or later, they're going to get antibiotics and IV fluids. Now, they'll still get a recommendation for surgery, but it's not going to happen before 6am. Hell, if they call at 8pm or later I'll probably still wait until morning.

I should mention that septic or complicated cases are another matter.

Anonymous said...

The study fails in numerous ways; however, it ASSUMES all cases of "appendicitis" are, indeed, appendicitis--and not carcinoma of the appendix, carcinoid of the appendix, mucocele, lymphatic obstruction, or some other masquerading disease of the appendix. There are still many other diseases (as every surgeon knows) of the appendix and require appendectomy. Want to try antibiotics on carcinoma? Go ahead and explain that one in court using the study cited. I don't buy into any of this. Appendectomy, now laparoscopic appendectomy, is tried, true, it works, and the patient won't get C.Diff. or recurrent appendicitis--a result of using antibiotics. I had an attending once say, "The best surgeons are the internists." Here is a perfect example of "the best surgeon knows when to operate...and most importantly, when NOT to operate."

Skeptical Scalpel said...

Artiger, you better have faith in your ED docs and nighthawk radiologists. Just sit on one perfed appy overnight and see what happens if there's a complication.

Anon, I agree. You might want to read this. https://twitter.com/AmCollSurgeons/status/677533837182820356

artiger said...

Scalpel, if they're perfed and sick, I'll be up there. If they're perfed but stable (assuming the CT was read as not perfed), my management is still morning lap appy.

We have the same radiologists, day or night.

Skeptical Scalpel said...

Same radiologists? Good for you.

Anonymous said...

Anonymous Europe: I am back from being on call. This appendicitis topic intrigues me. Using an Abdominal CT scan for an appendicitis is something we would never consider here in Europe, especially in children. It is just clinical examination, lab stats and ultrasound. If it is still unclear we perform the appendectomy. The trend is also laparoscopy here, but first a trainee (me:)) needs to learn the open procedure and only then are they allowed to first assist in the laparoscopic procedure.
This article with the antibiotics is a complete bogus. I seriously doubt that just giving antibiotics would help with a perforated appendix with an abdominal abscess.....

Anonymous said...

Merry Christmas and happy Holidays!:)

Skeptical Scalpel said...

In fairness, perforated appendicitis with an abscess would not meet the criteria for treatment with antibiotics alone. The antibiotic regimen is meant only for patients with simple appendicitis. That's why a CT scan or US is necessary to rule out complicated appendicitis.

Anonymous said...

A few counterpoints:

1. There are several studies, not just one.

2. The 25% "failure" rate is based on protocols that demand that any recurrent belly pain within one year be treated with immediate surgery. Some of those people do not actually have appendicitis.

3. True, cutting out the appendix permanently removes risk of appendectomy, just as hacking out the colon would negate future risk of recurrent colitis. If you have no indicators of a high risk of recurrence, preferring the former is likely to be based on the false assumption that the appendix has no function and (like older women's breasts and uteri....) serves only as a cesspool of risk.

3. Children are routinely compelled to undergo the interventions culturally preferred by the staff of the hospital where they happen to be. Adult patients aren't physically forced into surgery, but if they are told their only options are surgery or death, either falsely or because you will refuse to prescribe the life-saving antibiotic, there is serious coercion. I have had a family member subjected to a life-altering procedural malpractice cascade - and no, we didn't sue, though we should have - under partly comparable circumstances, and it inclines both of us strongly in favor of avoiding surgery: we would rather not have things done to us that can't be undone without permission, or at all.

4. It's a patient's legal right to know about all real treatment options. Homeopathy for appendicitis is a red herring, as it is not a real option - though choosing death always is. However, antibiotic treatment is a real option. There is no blood-appendix barrier; the reason we treat infection only of that one body part with immediate surgery is historical, i.e., the surgery was invented and usually survivable before modern antibiotics. If you were starting from scratch to devise a treatment for this disease (or rather, spectrum of diseases) in the modern era, the assumption would surely be that you begin with drugs rather than cutting, just as you would not cut out a lung as the first treatment for pneumonia. That makes universal surgery a cultural preference, which patients have the right to reject.

Skeptical Scalpel said...

1. Yes there are several studies. As I noted in a post on 12/28, a recent review article listed them. The pooled recurrence rate for antibiotic treatment of appendicitis is 35%.

2. You say some of those with recurrent abdominal pain don't have appendicitis when they are operated on. How do you know this? Also as I noted in my 12/28 post, some of the studies of surgery versus antibiotics used clinical findings only to include patients. Therefore some of the people who got better on antibiotics may not have had appendicitis too.

3. I'm not sure what your point is.

4. I can't think of another disease where we would accept a 35% failure rate within approximately one year of treatment. If we had started with antibiotics as the treatment of acute appendicitis, we would have been looking for a better treatment. With a greater than 99% rate of cure, appendectomy would surely have been chosen as the better option.

Anonymous said...

FYI, there is a large CER study on appendectomy vs. antibiotics for uncomplicated appendicitis getting under way: http://www.pcori.org/research-results/2015/comparing-outcomes-drugs-and-appendectomy-coda.

Skeptical Scalpel said...

Yes, I was aware of it. The fact that it is taking place here in the US should help to settle most of the issues [I hope].

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