How to operate on the wrong site

Here’s a story that illustrates how to operate on the wrong site. 

In a news article about some sanctions that the State of California imposed on certain hospitals for misdeeds, the following summary of one incident appeared. I have added some emphasis in bold.

A six-year-old boy had to undergo a second surgery to remove a growth after a surgeon performed the wrong surgery on his tongue.

"This failure resulted in [the patient] being exposed to the risks of bleeding and infection, and unnecessary exposure to the risks associated with anesthesia that was needed to perform the right procedure," state documents say.

The surgeon told investigators that he couldn't be sure whether a time-out [explanation: a pause in the preoperative routine to ask all members of the OR team if they all agree on who the patient is and what the operation will be], which was said to have transpired according to the hospital's policies, was ever done.

"Either time-out was not done or it was done, but I could not recall what procedure was said," the surgeon told state investigators. The surgeon then said that team members, who should have known the correct procedure, should have asked why there was no specimen of tissue from the removed growth.

Asked whether he examined the patient prior to the surgery, the surgeon replied, "Usually, I don't examine anybody. In this case, there was no time to do pre-operative visit. From now on, I need to see the patient prior to surgery."

The hospital was fined $50,000.

I can’t blame anyone who read that story for wondering just what the hell we are all doing in hospitals today. 

The wrong operation, a tongue-tie release, was performed. The surgeon couldn’t recall if a time-out was done. He blamed the staff for not mentioning that no specimen was obtained. He apparently had seen the patient in his office but did not re-examine him on the day of surgery and did not usually do so. It’s not all bad though. “From now on,” he will start seeing the patients before he operates. 

The official report cites the hospital for failing to follow its own procedures regarding verification of the type of operation to be performed. 

It is basic good practice and common sense to examine every patient again on the day of surgery and reconfirm the nature of the procedure, the correct side and answer any questions the patient or family might have. For example, I have seen lymph nodes that I was asked to biopsy shrink dramatically in the 10-14 days between my office examination and the planned surgery day.

Who obtained consent from the child’s mother? What did the consent form say? Didn’t the circulating nurse or anyone else look at the form to verify what operation was to be done? Don’t the nurses enforce the time out rule? What was the anesthesiologist doing?

Maybe the fine and the hospital’s “system error” type plan of correction, which entails monitoring 30 time outs per month for an unspecified period of time, will prevent this from happening again.

I doubt it. 

See how easy it is to operate on the wrong site? That’s why people can defeat any system correction plan.

Duh? Postoperative complications lead to readmissions

God knows I’ve written more than my share of papers that the Nobel Prize Committee has rightfully chosen to ignore. I understand that academicians need to publish in order to keep their jobs. Writing a paper is hard work and I don’t really want to demean it.

A paper reports that complications of surgery are linked to increased rates of readmission, and this seems rather obvious to me. It got a lot of media attention, and comment is needed.

The study, published in the Journal of the American College of Surgeons, looked at the records of over 1400 patients who had general surgical operations and found that 163 (11.3) were readmitted within 30 days of discharge.

The authors make some good points such as readmissions were not related to age, race, sex, or certain co-morbidities such as diabetes, smoking status, COPD, ascites, hypertension, steroid use, unintentional preoperative weight loss, history of bleeding disorders or renal disease. Readmissions were significantly more apt to occur if patients had preoperative dyspnea, open wounds or disseminated cancer.

But the main findings that readmissions were due to complications and the more complications a patient had, the more likely he was to have been readmitted, are not exactly earth-shattering.

The press release and articles accompanying the paper’s publication were a little over the top.

Here are some quotes from a few of the many articles about this research:

From the American College of Surgeons website: Findings published in the Journal of the American College of Surgeons lead researchers to devise a patient safety plan to decrease complications for the benefit of patients and hospitals.

From a site called Redorbit: [The surgeon-author] reported that the results of this investigation provided a framework for his research team to develop a simple complication-prevention plan that minimizes the risk of surgical patients developing complications.  

No such plan is mentioned in the paper.

From Infection Control Today: This patient safety approach includes engaging the postoperative care team to start transition-of-care planning early—especially for high risk patients—to encourage early discharge from the hospital. This too is not specifically stated in the paper nor is it supported by the data. In fact, early discharge might result in more readmissions. Who knows?

Incidentally, the press release, in most cases printed verbatim by the medical news websites, was wrong about the data forming the basis of the study. It says, “Researchers conducting this retrospective study analyzed patient records from hospitals that were enrolled in the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP), which is the leading nationally validated, risk-adjusted, outcomes-based program to measure and improve the quality of care in private sector hospitals. Data from Emory University Hospital was merged with ACS NSQIP data to identify unplanned readmissions.” Not so. The paper included patients who were operated on only at Emory University Hospital.

Slight digression: Even if readmission rates were not increased by complications, I would be in favor of a plan to reduce them.

One of the reasons I am skeptical about a lot of things is that when you look into the details, you often find that the “spin” produced by stories about a research paper is not always matched by its content.

I’m not the only one. A French study on the PLoS One website in September found that the spin generated by press releases and abstracts is highly likely to influence news reports about the research and overstate its beneficial effects.

I've written before about the need to read the whole paper and not just the abstract. You must be cautious about what is written in the press release too.

Moderate maternal alcohol use lowers children’s IQ (not)

A new study shows that children of mothers who drank as little as 1 to 6 units of alcohol per week had children whose IQs at age 8 were statistically significantly lower than those of children who mothers abstained.

This finding was widely reported by news media yesterday. Google “IQ alcohol” and you will find many articles which uncritically describe the findings of the study. As is the case in many such articles, quotes from the press release accompanying the paper’s publication appear to have been liberally used.

The major problem with this study is one that I’ve written about before. Results that are statistically significant may not necessarily be clinically significant.

The difference in IQ between the two groups of children was 1.8 points. Do you really think that an IQ difference of 1.8 is going to be a life-altering finding for a child? I don’t.

IQ tests are often unreliable and if taken more than once can yield different results. A difference of 1.8 points is well within the margin of error of such tests. One source I found states that the margin of error of the IQ test used in this study is a minimum of 5 points. The children in this study were 8 years old when they took the test.

The study, done by a group in Bristol, England, was published on PLoS One and the full text is available here. Caution is advised if you plan to read it. There are many other problems to consider.

Data collected for this paper were pulled from another study which was done from 1992 to 2000 about the genetics of alcohol metabolism. The primary focus of the original study was not the hypothesis of the IQ study.

A unit of alcohol was defined as 8 grams by the authors. Since I was not familiar with what 8 grams of alcohol really meant, I looked it up. A “standard drink” was said to contain anywhere from 8 (in the UK) to 14 grams (in the US) of alcohol.

Here’s a quote from the paper’s “Methods” section, “At approximately 18 and 32 weeks of pregnancy women were also asked on how days during the past month they had drank [sic] 2 pints of beer (or the equivalent amount of alcohol), any women who reported doing this on at least one occasion was classified as a binge drinker in our analysis of the association between genotype and binge drinking.”

Really? Two pints of beer on one occasion makes a woman a binge drinker? Depending on the type of beer, a pint contains 2 to 3 units or 16 to 24 grams of alcohol.

To help you understand the paper better, here is a table:

I asked my wife what she thought of this study and she said, “I think the women who drank were probably more fun to be with.”

“Duty, Honor, Country” or “Generals Gone Wild”?

There are currently three high ranking military officers in trouble for alleged sexual misadventures. Unless you’ve just returned from the international space station, you’ve probably heard about former general David Petraeus’s schoolboy-like infatuation with his biographer, Paula Broadwell, and General John Allen’s voluminous email exchanges with Jill Kelley, described by some as a  “Tampa socialite” (an oxymoron?) and by others as a Real Housewife of Tampa.

But the third, General Jeffrey Sinclair, who really takes the cake. He is currently being court-martialed for the following charges: forcible sodomy, wrongful sexual conduct, attempted violation of an order, wrongfully engaging in inappropriate relationships, misuse of a government travel charge card, possessing alcohol and pornography while deployed, maltreatment of subordinates and fraud.

One of his apparent victims, an Army captain, testified last week that he threatened to kill her if she told anyone about an affair they had for some three years.

He was legendary for his mistreatment of women subordinates. When confronted about that, he allegedly said, “I’m a general; I’ll do whatever the [expletive] I want.”

Many of the allegations against the three generals involved their behavior while they were in positions of high responsibility in Afghanistan. Petraeus was the highest ranking general there. Allen replaced him. Sinclair was in command of the prestigious 82nd Airborne Division.

The conduct of these three men is deplorable and inexcusable on many levels, but here’s a point of view that I have not heard anyone yet express.

I have six children, who fortunately have not had to serve in the military. I can’t stop thinking about all of the families of soldiers who have died in Afghanistan. How would you feel if your son or daughter had been killed after being sent into harm’s way by one of these generals?

Your kids are dying. Meanwhile, General Petraeus is “All In”; General Allen is emailing his little Tampa socialite; General Sinclair is drinking, misusing credit cards and sodomizing women on the base.

When did these guys find the time to run the war?

FOOTNOTES:

“Duty, Honor, Country” is the motto of the US Military Academy (West Point)

Story of testimony that Sinclair threatened to kill a female captain

Story describing charges against Sinclair

Story containing Sinclair quote about being a general

Study: 31% of general surgery residents need remediation. Why?

A recent paper in Annals of Surgery depicts the rate of resident remediation over a decade or so at six general surgery programs in California. The authors reviewed the records of 348 categorical general surgery residents and found that 107 (31%) required mediation with knowledge deficits the primary reason in 74%. Other issues, such as interpersonal and communication skills, patient care and professionalism, were cited far less often.

Need for remediation did not correlate with attrition. Remediated residents left programs at a rate of 20% compared to 15% of non-remediated residents, p = 0.40.

On multivariate analysis, only two factors were associated with the need for remediation. One was USMLE Step 1 scores which were lower in the remediated group. But the median difference in scores between remediated and non-remediated residents was only 7 points with wide and overlapping interquartile ranges, and both median scores were above the average for all medical students over the years of the study.

The other factor was quite remarkable. Remediated residents were significantly more likely to have received a grade of "honors" for their medical school clerkship and surgery. How can this be?

The authors speculated, "One thought is that medical students start residency under-prepared for the rigors of surgical residency." Now where I heard that before? I have previously blogged (here) about the unrealistic third-year experiences of medical students on surgical rotations. While I agree that they likely are not ready for the workload, I'm not sure what it has to do with the primary reason for their poor performance—a perceived knowledge deficit. Does hard work cause them to forget everything they’ve learned or are they taught the wrong stuff in med school?

I think not. The real reason may be found in the way medical students are graded. A group from Harvard looked at medical school grading systems and found that honors grades in third-year surgery clerkships are given to an average of about 30% of students ranging from a low of 7% to an mind-boggling high of 67%. I understand that those accepted to med school are smart, but how is it that two-thirds of the class can achieve honors in surgery? Could it be that some of the honors grades given to residents who eventually needed remediation were not warranted?

If you would like to read more about this, you may read the full text of the paper on medical school grades here or a summary on my blog.