More negative data about the nonoperative management of simple appendicitis

If you think I am the only one urging restraint in the adoption of nonoperative management of patients with uncomplicated appendicitis, you are wrong. A pediatric surgeon and a research fellow from Harvard and Massachusetts General Hospital have recently published their thoughts on the matter online in Annals of Surgery.

They call their opinion piece “Ulysses Syndrome” because they liken the fate of those undergoing nonoperative management to the “10-year ordeal filled with unexpected peril and ample misfortune” that befell Ulysses while attempting to go home.

Here are a few highlights.

Why public reporting of individual surgeon outcomes should not be done

Please take a look at my latest post on Physician's Weekly. It's called "Why public reporting of individual surgeon outcomes should not be done."

Click here for the link.

The occasional surgeon

On the Forbes website, Dr. Robert Pearl writes

"When I was selected to become CEO of The Permanente Medical Group, the Permanente half of Kaiser Permanente, the time required for my responsibilities forced me to give up doing surgery on a regular basis. But every year since then, during the week between Christmas and New Year’s Day, I have returned to the operating room. The timing works, as the leadership demands become minimal and it’s unlikely I’ll suddenly be needed to fly to another part of the country. It’s a magical time for me, contrasting dramatically with my world as CEO. For several hours each day, my focus is not on millions of Kaiser Permanente members—or, for that matter, on all the complexities of healthcare policy, politics and strategy—but, rather, on a single patient at a time."

Dr. Pearl is a Yale medical school graduate who trained at Stanford and has been board-certified in plastic surgery since 1979. The American Board of Plastic Surgery did not start requiring maintenance of certification every 10 years until 1995.

We do not know what specific surgical procedures he does during his magical time. Is he removing moles, performing reconstructive surgery, or doing facelifts and nose jobs? Do his patients know that he only operates a few days per year? What happens if a wound complication requiring revision surgery arises? Who follows up his patients?

No improvement in complication rates after instituting an operating room checklist

A before and after study at the University of Vermont Medical Center found that a 24-item operating room checklist did not significantly reduce the incidence of any of nine postoperative adverse outcomes.

More than 12,000 cases were studied, and outcomes included mortality, death among surgical in patients with serious treatable complications, sepsis, respiratory failure, wound dehiscence, postoperative venous thromboembolic events (VTE), postoperative hemorrhage or hematoma, transfusion reaction, and retained foreign body (FB).

After the checklist was established, respiratory failure rates decreased significantly on the initial analysis, but the difference disappeared when the Bonferroni correction* was applied to the data set.

Why didn’t the checklist work? I have discussed this in previous blog posts here and here. As was true in previous papers of this nature, many of the complications studied—respiratory failure, wound dehiscence, transfusion reaction, postoperative hemorrhage or hematoma—could not have been prevented by a checklist.

Less crowded EDs = less waiting & "big data" isn't so big

Two recent papers caught my eye. As usual, I will preface my critiques with a disclaimer that I have never written a Nobel Prize-winning paper myself.

The first paper, “Emergency department ‘undercrowding’ is associated with decreased waiting times” appeared online in the journal Emergency Medicine Australasia.

The authors looked at emergency department patient numbers and waiting times before and after a nearby tertiary care hospital opened a new emergency department.

Their main finding was that after the new ED opened, their ED saw 28% fewer patients with a concomitant decrease in patient waiting times of 15 minutes from 26 to 11 minutes with p < 0.001, a significant difference.

They concluded, “Wait times are strongly associated with patient presentation numbers.” Furthermore, “Controlling demand may benefit patient processing, flow, and patient perceptions of level of care.”

Variation is not causation

I made a rookie mistake in statistics of the “correlation is causation” genre by confusing variation for causation in the recent JAMA Surgery paper referred to in my last post. I contacted Dr. Timothy M. Pawlik, the lead author of the Johns Hopkins study, who said the following:

"The model is explaining and attributing variation in readmission and not attributing readmission itself to the different domains. The model suggested that only 2.8% of the variation in readmissions was attributable to surgeons. This is different than saying that only 2.8% were the 'fault' of surgeons. A more accurate interpretation would be that only 2.8% of the variation seen in readmissions was attributable to provider level factors. The majority of the variation in readmission was due to patient factors."

He added that some of the 82.8% variation in readmissions attributable (note: attributable doesn’t mean it’s the patient’s fault) to the patient could be modified by better medically managing patients' comorbidities or not operating on some of these patients.

That readmissions can be explained by a single domain or a single person is simplistic. Dr. Pawlik's clarification confirms my original concern that attributing differences in patient outcomes solely to differences in technical quality of surgeons is probably inaccurate, statistically speaking.

Variation is not causation but variation is still a call to action. Regardless of who is to blame for unfavorable outcomes, surgery is a team sport. The incision is just as important as the community care. In this regard, I am certain that ProPublica and I are on the same side. Let’s work together so that we see the whole story behind the numbers.

Are surgeons the cause of high postoperative readmission rates?

No, according to a recent paper published online in JAMA Surgery.

The authors concluded, "The majority of the variation in readmission was attributable to patient-related factors (82.8%) while surgical subspecialty accounted for 14.5% of the variability, and individual surgeon-level factors accounted for 2.8%."

The investigators looked at data for over 22,000 surgical patients treated at Johns Hopkins and found the overall rate of readmission within 30 days was 13.2%. After the exclusion of those who performed fewer than 21 operations per year, 56 surgeons made up the study cohort.

Multivariable analysis showed significant non-modifiable patient-related factors associated with readmission were African-American race/ethnicity, more comorbidities, occurrence of postoperative complications, and an extended length of stay.

Variation in readmission by subspecialty ranged from 2.1% after breast, melanoma, or endocrine surgery to 37% following cardiac surgery.

The authors pointed out that this study "echoes growing concerns regarding the use of readmission as a quality metric based on its current methods."

Let's compare it to the controversial ProPublica Surgeon Scorecard.

Both the Surgeon Scorecard and the JAMA Surgery paper used data from the years 2009 through 2013. The scorecard involved only eight high-volume low-risk in-patient procedures while the paper looked at in-patient surgery of all types.

From an article written by the authors of the Surgeon Scorecard: "If a patient was readmitted to any hospital (not just the hospital where the surgery was performed) within 30 days of a surgery for one of the conditions we identified, we counted the case as a complication for the surgeon who performed the initial procedure."

What we learned from the JAMA Surgery paper raises some questions about the the Surgeon Scorecard. On Twitter, I asked for comment from Marshall Allen, the lead author of a white paper [not peer-reviewed] describing the methodology of the Surgeon Scorecard.

Between attacks on my credibility because I choose to use a pseudonym, he said that they did not count most readmissions as complications. It is unclear from the article, the white paper, or its appendices exactly which complications were included. For clarification, we could ask the "surgeon experts" who advised ProPublica, but their names have not been disclosed. They are anonymous, just like me.

According to the white paper, surgeons were blamed for 64,367 (46%) of all complications incorporated into the Surgeon Scorecard. Table 3 of the white paper lists the 20 most frequent complications. The top three, comprising 26,795 complications, were postoperative infection, iatrogenic pulmonary embolism, and infection/inflammatory reaction due to internal joint prosthesis.

Other studies have shown that not all occurrences of those three complications are attributable to a surgeon's misdeed. Among the rest of the top 20 causes of readmission were postoperative pain, fever, and dysphagia (difficulty swallowing)—again possibly not the fault of a surgeon.

So the JAMA Surgery paper says surgeons are responsible for 2.8% of readmissions within 30 days, but ProPublica's self-published white paper says 46% of all readmissions are due to something a surgeon did or did not do.

Who to believe?

Note added at 7:27 a.m. on 9/2/15: See my next post for a clarification about causation and variation. 

The full text of the peer-reviewed JAMA Surgery paper is available here.

In 22% of kids with appendicitis, antibiotics do not prevent perforation

Those clambering aboard the "antibiotics for appendicitis" bandwagon should read this interesting paper about appendicitis in children.

A group of emergency physicians from Maimonides Medical Center in Brooklyn, New York found that "Increasing in-hospital time delay from ED presentation to OR appendectomy is associated with increased risk for developing appendicitis perforation in children who present with CT-documented uncomplicated appendicitis."

Children with simple appendicitis who were taken to the operating room longer than 9 hours from the time of ED presentation were much more likely to develop a perforation than those who had surgery in less than 9 hours.

During the four years of the study, 404 consecutive children ≤ 18 years of age had a CT scan diagnosis of acute appendicitis; 156 (38.6%) had evidence of perforation at the time of presentation and were not included in the final analysis.

Why in-hospital deaths are not a good quality measure

You may be tired of hearing about the Surgeon Scorecard—the surgeon rating system that was recently released by an organization called ProPublica. Like many others, I have pointed out some flaws in it. You can read my previous posts here and here.

I had decided to stop commenting about it because enough is enough, but a recent paper in the BMJ raises a question about one of the criteria ProPublica used to formulate its ratings.

ProPublica defined complications 1) as any patient readmission within 30 days and 2) "any patient deaths during the initial surgical stay."

The authors of the BMJ paper randomly selected 100 records of patients who died at each of 34 hospitals in the United Kingdom. The 3400 records were reviewed by experts to determine whether a death could have been avoided if the quality of care had been better.

The number of patient records in which a death was at least 50% likely to have been avoidable was 123 or 3.6%.

There was a very weak association between the number of preventable deaths and the overall number of deaths occurring at each hospital. By two measures of overall hospital deaths, the hospital standardized mortality ratio and the summary hospital level mortality indicator, the correlation coefficient between avoidable deaths and all deaths was 0.3, not statistically significant.

From the paper: "The absence of even a moderately strong association is a reflection of the small proportion of deaths (3.6%) judged likely to be avoidable and of the relatively small variation in avoidable death proportions between trusts [hospitals]. This confirms what others have demonstrated theoretically—that is, no matter how large the study the signal (avoidable deaths) to noise (all deaths) ratio means that detection of significant differences between trusts is unlikely."

The Surgeon Scorecard was derived from administrative data. No individual analysis of patient deaths was undertaken. According to a ProPublica article discussing some key questions about their methodology, "As for deaths, we took a conservative approach and only included those that occurred in the hospital within the initial stay."

Maybe that wasn't such a conservative approach after all.

And maybe we need to rethink that 2013 paper claiming that medical error caused up to 440,000 deaths per year.

Gallbladder surgery: Double jeopardy

Last month, I blogged about a paper from China that advocated removing just the gallstones and leaving the gallbladder in place. I wrote that such procedures had been tried in the early days of gallbladder surgery and failed because the stones recurred. You can read that post here.

It's not often that one gets to see almost immediate follow-up on a blog post like this, but I am happy to say that I can share a brief story with you.

A 44-year-old man (who consented to my blogging about him) underwent a cholecystectomy by a friend of mine a few weeks ago. The patient presented with right upper quadrant abdominal pain. He said that he had gallbladder surgery in a South American country in 2009 and had a large right subcostal incision to show for it.

In the emergency department of the hospital, a CT scan showed a large gallstone in what appeared to be a shrunken gallbladder. My friend obtained a copy of the operative report and a handwritten note from the original surgeon. See below.

The surgery that had been performed was a partial cholecystectomy and removal of a 6 cm gallstone.

My friend (and yes, he is still my friend) performed a robotic cholecystectomy. He said the surgery was difficult due to omental adhesions and the small size of the gallbladder. The specimen contained six 2 to 3 mm stones. The patient did well and was discharged.

OK, one case is an anecdote and doesn't prove anything, but its timely appearance doesn't hurt my position that just removing the stones won't cut it. (Pun intended.)

Gallbladder surgery goes back to the future in China

Chinese surgeons claim taking out just the gallstones without removing the gallbladder works well for most patients.

There were 65 patients with gallstones, 61 of whom underwent successful minimally invasive surgery for removal of just the stones leaving the gallbladder in place. The other four patients had laparoscopic cholecystectomies for various technical reasons. After an average follow-up of 26 months, the stone recurrence rate was 4.9% (3 cases).

Not mentioned in the abstract but noted in the methods section of the full article is that all patients were given a 3-month course of ursodiol postoperatively. The authors said it "adjusts the abnormal lipid metabolism in the gut-liver axis and prevents stone recurrence." This statement contains some truth up until the word "and." It's not clear how a short course of ursodiol would help.

Before the advent of laparoscopic cholecystectomy, doctors tried dissolution with ursodiol as a primary treatment. It worked 30-80% of the time for pure cholesterol stones, not those that were pigmented or calcified. About 50% of the time the gallstones recurred after the medication was stopped if the follow-up was long enough, that is, at least 7 years. [I had to go back to 1988 for this reference.]

Well over 100 years ago when open gallbladder surgery was first attempted, surgeons soon learned that removing the stones was inadequate treatment due to a high rate of recurrence.

Since the gallstone removal procedure involved general anesthesia and laparoscopy with two 10 mm and two 5 mm ports anyway, it makes absolutely no sense to just remove the stones. Most laparoscopic cholecystectomies are done with one 10 mm and three 5 mm ports so there is one less large incision which decreases the risk of postoperative hernias.

Here are some more issues.

Preoperatively, only 26 of the patients in the series had biliary colic. Gallstones with "atypical upper gastrointestinal symptoms" were present in 34, and 5 had no symptoms. Surgeons in the US generally would not have operated on patients in the latter two categories.

No mention was made of the duration of the operation, which involves laparoscopy with the 4 ports as noted above, insertion of a choledochoscope into the gallbladder, grasping the stones with a basket an unstated number of times, irrigation, and suture closure of the gallbladder wall.

The authors also that said except for the three recurrences of stones, gallbladder function was normal postoperatively. This was determined by ultrasonography after a fatty meal which took place every 6 months postop.

The three reoperations were done when stones were found by the ultrasound. Of those three, the authors said, "One patient remained asymptomatic, 1 patient experienced biliary colic, and the other patient had non-specific upper gastrointestinal symptoms (flatulence and dyspepsia)."

I don't see this procedure catching on here in the US. Do you?

UPDATE 3/25/14: See a follow-up post on this subject here.

"Medical errors kill hundreds of thousands each year in the US"

How about that headline?

It appeared on RT.com, "the first Russian 24/7 English-language news channel which brings the Russian view on global news."

The story, which originally ran in November of 2013, was resurrected again on Twitter yesterday. It's subject was a paper that claimed as many as 440,000 patients die from medical errors in the United States every year.

Back in September, I criticized the study because it assumed that every death was both preventable and caused by a medical error. Neither assumption is correct. It also extrapolated the doomsday figures from only four other papers describing just 38 deaths.

In that post I said, "Inflating the incidence of these problems does nothing but further erode the already shaky confidence of the public in the medical profession. And creating the impression that such events are totally preventable leads to unrealistic expectations and unachievable goals."

So why am I bringing this up again?

Take a look at a few of the comments from the RT.com story [printed verbatim]:

Old news, as many as a million die each year cause of doctor errors. Thats why their malpractice insurance is so high. Legal unintentional homicide.

It's convenient to claim such deaths are errors but a great many are deliberate. They know such incidents will not be investigated as crimes. It's very easy to conceal a murder if no one is looking. The medical system is completely corrupt.

if they'd stop getting high in med school and pay more attention maybe this wouldnt happen. then there is their attitudes. Heaven forbid anyone needs medical care, that's for sure.

According to CDC, medical errors is not even a category of death, but they published research that indicates drunk drivers kill about 10,000 yearly. If that is correct, then doctors kill almost twice that many every hour of every day -. MADD should be mad about DEADLY DOCTORS. You are 40 times more likely to be killed by a deadly doc than you are by a drunk driver. And yet - where is the "funding" for this deadly phenomena?

I know those who comment on the Internet usually do not represent the views of rational individuals, but it infuriates the hell out of me that the 440,000 deaths from medical errors estimate, which is clearly wrong, is repeatedly trumpeted all over the place and so readily believed.

By the way, the paper appeared in the Journal of Patient Safety, which recently underwent an editorial change due to a kickback scandal involving former editor Dr. Charles Denham. That's another story (here).

Do doctors and hospitals make mistakes? Yes. Can we improve? Yes. Does it help to exaggerate the magnitude of the problem? Emphatically, no.

Antibiotics instead of surgery for appendicitis? No way

A retrospective study from California claims that the nonoperative management of simple appendicitis may be safe and is worth studying further.

Why am I not convinced? Because every time this subject comes up, the paper purporting to show that antibiotics are superior or even equal to surgical treatment is flawed. The trend continues with the current paper du jour which appears online in the Journal of the American College of Surgeons.

This study looked at the records of over 231,000 patients with uncomplicated appendicitis during the years 1997 to 2008. Only 3236 (1.5%) of those patients were treated non-operatively, and 10.3% of them had either a failure of antibiotic treatment or a recurrence of appendicitis during follow-up with 3% of those having perforations. Mortality rates were very low (appendectomy 0.1%, antibiotics 0.3%) and not significantly different, and hospital charges were similar in the groups matched with propensity scoring. Length of stay was significantly longer for those treated with antibiotics 3.2 days vs. 2.1 days, p < 0.001.

Sounds great, right?

I will not go into detail about the some of the important problems with this paper such as the fact that before the statistical manipulation with propensity scoring, the baseline characteristics of the patients in both groups were significantly different in all but one category. In table 1 of the paper, the number of patients available for follow-up was exactly the same as the number entering the study. That means that not a single patient was lost to follow-up, which is hard to believe since people occasionally move out of state. The reasons that patients did not undergo appendectomy could not be determined from the administrative database used.

Here are the key issues.

The paper was based on discharge diagnoses. Even with the use of CT scans for diagnosis, some cases of what seem to be simple appendicitis turn out to be more extensive at surgery. Had these patients been treated with antibiotics, the results would have been disastrous. And as a paper from the UK reported, administrative databases are notoriously unreliable for use in clinical studies.

The biggest problem with the paper touting antibiotics for appendicitis is that it includes patients over the course of the 11 years from 1997 to 2008. During that time and continuing to the present, the surgical technique of appendectomy has evolved.

If you look at the same database used by the authors (California Office of Statewide Health Planning and Development Patient Discharge), you will find that in 1999, appendectomies were done laparoscopically in 7574 of 36,740 cases or 21% of the time. Fast-forward to 2012, and note the converse—laparoscopic appendectomy was performed in 35,393 (79%) of 44,582 appendectomies.

Why is this important? The average length of stay for laparoscopic appendectomy for simple appendicitis is one day or fewer. This is less than half of the time stated in the comparison with antibiotic treatment.

In the January 2014 issue of the Journal of Trauma, a study reported 345 patients who had a laparoscopic appendectomy for uncomplicated appendicitis. Of those patients, 305 (88%) were discharged home from the post anesthesia care unit. The average time from admission to operation was five hours, and the average time spent in the PACU was just under 3 hours. The reasons that the 40 (12%) patients were admitted were lack of transportation in 19, pre-existing comorbidities in 15, and postoperative morbidity in 6. Only 4 of the patients who were discharged directly from the PACU required readmission. Thus, total complications (postop morbidity plus readmission) numbered 10 (2.8%).

Treating appendicitis with antibiotics also exposes patients to the risks of C. difficile colitis and other side effects of the drugs. The complications associated with laparoscopic appendectomy for simple appendicitis are few, and more importantly, the appendix is gone forever.

The authors concluded: "While the rate of treatment failure was 5.9% in non-operative patients, it was only 0.1% in operative patients. With concerns over controlling 30-day readmission and rising healthcare costs, these shortcomings may be substantial barriers to the consideration of non-operative approaches."

A randomized trial of antibiotics vs. surgery for uncomplicated appendicitis is underway in Finland. Judging from the wording of the abstract describing the trial, the authors are markedly biased toward the use of antibiotics. Despite this, let's hope it sheds some much needed light on this subject.

I don't understand why investigators, especially surgeons, continue to push antibiotics as an alternative to appendectomy. For simple appendicitis, laparoscopic surgery is quick, safe, and definitive.

Do more hospital resources equal better care?

For surgical patients, the answer is "Yes."

A recent study from England found that mortality rates for patients admitted with high-risk general surgery diagnoses were significantly lower in National Health Service Trust hospitals that used more CT scans and ultrasounds and had more ICU beds.

During the first decade of this century, nearly 368,000 patients were admitted as emergencies to English hospitals with surgical diagnoses carrying mortality rates in excess of 5%.

The diseases were bowel obstruction, liver/biliary conditions, hernias with obstruction or gangrene, peritonitis, gastrointestinal ulcers, perforated diverticulitis, bowel ischemia and miscellaneous diagnoses.

The 30-day risk-adjusted in-hospital mortality rate for the eight illnesses was 15.5% with a range of 9.2% in low-mortality hospital trusts (LMHTs) to 18.2% in high mortality hospital trusts (HMHTs). An operation was performed in 37.4% of patients, and 14.9% were readmitted within 28 days.

Three factors significantly differentiated LMHTs from HMHTs:

LMHTs had 20 ICU beds per 1000 beds vs. 14 for HMHTs, p = 0.017.

LMHTs performed 24.6 CT scans per bed per year vs. 17.2 for HMHTs, p < 0.001.

LMHTs performed 42.5 ultrasounds per bed per year vs. 30 for HMHTs, p < 0.001.

Some limitations of the study included the fact that it was based on administrative data. There was no way to determine if the increased use of imaging or availability of ICU beds had a direct effect on patients admitted with emergency surgical diagnoses. Also, variables such as delays in surgery or competence of surgeons could not be investigated.

Despite its limitations, this study is provocative.

No doubt the HMHT hospitals, which have fewer ICU beds and perform fewer imaging studies, are not as expensive.

But the study suggests that if you have the misfortune to arrive at an HMHT hospital with one of the surgical diagnoses listed above, you may have twice the chance of dying than if you had gone to an LMHT hospital that utilizes more resources.

This study is supported by a Viewpoint article in October's JAMA Surgery which looked at two studies of postoperative care in the UK and Europe. In both papers, many seriously ill postoperative patients did not receive appropriate levels of critical care. "Among patients who died during hospitalization after major surgical procedures in the United Kingdom in 2001, approximately 8.5% were admitted to an ICU at some point in their hospital stay. During the same period in the United States, this figure was 7 times greater, 61%."

In the European study, only 5% of surgery patients had planned admissions to intensive care, and 75% of those who died postop did not spend any time in an ICU.

The authors added, "in efforts to achieve good surgical outcomes, there really may be no free lunch: tradeoffs between cost and quality are inherent to the contemporary delivery of intraoperative and postoperative care."

What do you think?