Tuesday, November 26, 2013

Despite checklists, wrong-site surgery still occurs. Why?

Not long ago, two California hospitals were cited by the state for wrong site surgery.

At one hospital, a skin incision was made in the right groin of a patient who was to have had a left orchiectomy. Fortunately the error was discovered, and the skin was closed. The correct testicle was removed. To his credit, the surgeon told the patient and his wife what happened immediately after the operation.

An investigation found that the patient's groin had not been marked. The time out did not prevent the error because the OR team did not verify the operative site as the protocol mandates. In other words, they had gone through the motions.

The hospital was fined $75,000.

The other California case did not turn out as well. Instead of removing a cancerous left kidney, surgeons did a right nephrectomy. The error was not discovered until the pathology report was reviewed. A number of assumptions and misunderstandings contributed to this error for which the hospital was fined $100,000.

Friday, November 22, 2013

University to offer 6-year combined college + law degree

The University of Iowa College of Law has established a new program which will enable students to begin law school after three years of undergraduate study. After six years, the student will have a J.D. degree, and credits earned in the first year of law school will count toward an undergraduate degree.

The school says this is not for everyone, but rather only for the "right" students.

Not only will the right students save a year of college tuition, they will also be able to look for work as Starbucks baristas a year sooner than law school graduates who spend four years getting their undergraduate degrees.

Related posts.

Thursday, November 21, 2013

Patient falls off OR table: System error or human error?

An anesthetized patient fell to the floor headfirst from an operating room table during a laparoscopic appendectomy in Scotland. The table had been tilted into an extreme head down position to facilitate the operation. Fortunately, no injury occurred.

The Edinburgh Evening News account says that there were 10 staff members in the room at the time the case started, but no one had placed a safety restraint on the patient.

A follow -up story noted that the hospital has experienced 11 other major surgical errors in the last year including two instances of wrong-site surgery and a case in which five swabs were left inside a single patient.

An investigation by the hospital noted that the level of situational awareness of the operating room staff was inadequate, and teamwork and communication were poor. In addition, the safety culture within the operating room was described as not highly attuned to patient safety.

The staff was also distracted by mobile phone use and idle chatter.

Instead of addressing the obvious human errors such as failure to place the safety strap, which in US hospitals is clearly the duty of the circulating nurse, the hospital's plan of correction focused on the following typical system-type corrections:

Compulsory training of 1200 staff. Although there were 10 staff for a laparoscopic appendectomy (in the US there would be 4, nurse, scrub tech, surgeon, anesthesiologist), I doubt that there are 1200 people working in the operating room of this 570-bed hospital. What will those not working in the OR have to gain from compulsory training? I wonder if anyone considered that 10 staff for an appendectomy is far too many, and that's why there was a lot of idle chatter. Six of the staff had nothing to do until the patient needed to be picked up off the floor.

A ban on talking at key times during operations. This one will be hard to enforce. Who decides what the key times are? I also don't see what it had to do with the incident since tilting the table would not be considered a key time in the case.

Daily meetings to improve patient safety. Good luck with that. What on earth are they going to discuss at daily meetings to improve patient safety? I predict that those meetings won't take place for more than 3 or 4 weeks.

Sanctions for staff who fail to meet the new standards. Also be hard to enforce. How will this be judged?

I would have talked with the nursing staff and asked them whose job it was to place the safety strap. If you want to make a system change, why not clearly specify which staff member is responsible for that action? And how about using a checklist?

Five years ago, the Scottish Patient Safety Program recommended using pre-surgery meetings and checklists to protect patients. The investigation showed that in this hospital, checklists were completed about 10% of the time and often not properly. The staff claimed that they didn't have time to do the checklists. Ten people in the room for an appendectomy and no one has time to complete a checklist?

Next I would have asked the anesthesiologist where he was. Usually the job of adjusting the table is his, and the controls are at the head of the bed. He should have noticed the patient was beginning to slide off the table and intervened.

Finally I would have asked the surgeon just how much head down tilt he needed. I have never even come close to having a patient more than about 30 degrees of head down during a laparoscopic appendectomy.

Patient falling from an OR table—human error.
Wrong site surgery—human error.
Leaving foreign objects inside patients—human error.

The OR staff of every hospital counts instruments and swabs. Wrong-site surgery is 100% avoidable. This hospital had a number of appropriate systems in place. The staff simply disregarded them. Creating more meetings and rules that are unlikely to be followed or make a difference will not solve the problem of a staff with a "can't do" attitude.

Tuesday, November 19, 2013

Study shows paying people to lose weight works. Or does it?

A new study looked at the effect of paying people to lose weight.

The authors randomized 100 people with BMIs ranging from 30 to 39.9 into four groups. Two groups received weight-loss education, one group with and one without payment. The other two groups received education plus behavior modification with again one group receiving financial incentives and the other not. To remain in the study, they were all supposed to have lost 4 pounds per month. Patients in the two financial incentive groups received $20 per month if they met their goal, and those not meeting the goal had to pay $20 per month which was pooled for a lottery among the participants at the end of the study.

A significantly larger percentage of those receiving remuneration completed the study. At the study's endpoint—12 months, the average weight loss for those in the paid groups was about 9 pounds compared to just over 2 pounds for the two unpaid groups. Using a two-way ANOVA, the incentives were estimated to have led to a weight loss of 6.5 pounds, which was statistically significant with a p value < 0.001.

The authors concluded, "Sustained weight loss may be achieved with financial incentives."

The paper was presented at the American College of Cardiology meeting last March and is available only in abstract form.

The study raises some questions.

The paid groups lost less than 1 lb per month. If the subjects were to have lost 4 lbs per month, why didn't they lose a minimum of 48 lbs, which would be 4 lbs x 12 months?

How durable was the weight loss? In other words, after the monetary incentive stopped, did the subjects regain the weight? It is well-known that many people regain weight after they go off their diets.

Does this study actually show that education and behavior modification are not very useful promoting weight loss? Then why should anyone bother?

It's one thing to do a study of 100 people, but if money truly is a good way to get people to lose weight, who is going to pay the millions of obese people in the US?

But here's the real question. How clinically important is a 6 to 9 lb weight loss for someone with a BMI of say 35?

If a man is 5'8" tall and weighs 230 lbs, he has a BMI of 35. If he loses 6 lbs, his BMI drops to 34. Does that decrease his risk for diabetes or hypertension? I think not.

This may be another example of a statistically significant result that is very likely not clinically important.

Thursday, November 14, 2013

Reality check: Hospital safety scores

Imagine you are sick and live in New York City. Your doctor tells you that you need major surgery. Luckily, you have excellent insurance and can go anywhere in the city for that operation.

Being a good consumer, you decide to check the HospitalSafetyScore.org website, which is sponsored by the Leapfrog Group, a nationally known patient safety organization.

You pull up a handy map of upper Manhattan and the lower Bronx to check the safety scores of hospitals in that area which is near your neighborhood.

A hospital on the Manhattan side (orange arrow) has a safety score of only "C" while over in the Bronx, there is an "A" rated hospital (blue arrow).

It's a no-brainer, right?

Clearly the safer of the two is the one with the "A" rating.

But consider this. The "A" rated hospital is Lincoln Medical and Mental Health Center, one of 11 hospitals owned and run by the city of New York. It is a teaching hospital. But there is little research going on, and there are no regionally or nationally recognized experts in just about any specialty of medicine or surgery practicing there.

The "C" rated hospital is New York Presbyterian, the main teaching hospital of Columbia University's medical school.

A 2012 patient safety study by Consumer Reports rated Lincoln as the 16th worst hospital for safety in the NY metro area. Presbyterian did not make that list of 30 such hospitals.

Healthgrades rates New York Presbyterian as #5 of 203 hospitals in New York State with 15 5-Star ratings and 11 quality awards. Lincoln was ranked at #88 with 3 5-Star ratings and 1 quality award.

US News & World Report published a list of the 18 best hospitals in the country that made its "Honor Roll." That list included New York Presbyterian at #7, and it was the highest rated hospital in the New York area.

Now which hospital would you choose?

Tuesday, November 12, 2013

Are "safety scalpels" safer than standard scalpels?

A Twitter follower wrote me this: "hospital making me use 'safety scalpel' w/retractable sheath. I've almost cut myself x 2. Do you know of any data about it?"

That got me interested because I like to question things. Was this going to be yet another rule without evidence?

I thought I would have to do an exhaustive search to see if anyone had ever studied the question of whether so-called 'safety scalpels' really are safer than standard scalpels.

I was pleasantly surprised to find a 2013 paper in the Canadian Journal of Surgery which reviewed the literature on the subject. The authors, from the University of British Columbia, found no studies that addressed harm reduction and the use of safety scalpels. A previous paper from Australia in 2009 also found no randomized trials of safety scalpel use.

In their discussion, the authors point out that the introduction of safety scalpels might have the opposite effect on safety due to factors such as personnel not being familiar with how they work and that safety scalpels have never been subjected to rigorous evaluation by failure mode and effects analysis. And they noted that injuries related to the use of safety scalpels have been reported.

Since there is no proof that safety scalpels are effective in reducing injuries, there seems to be no rationale for regulatory agencies or hospitals to mandate their use.

The paper noted that at least 24 different safety scalpels have been developed and approved for use in the United States. An Internet search confirmed that there are at least that many types of safety scalpels on the market.

I attempted to find a specific mandate about scalpels in the Needlestick Safety and Prevention Act of 2001 but was unable to do so. If the act says anything about scalpels, perhaps someone could let me know.

Among the issues with safety scalpels are that surgeons complain that they do not have the correct feel, quality or precision of standard scalpels.

The use of devices that allow for safer removal and replacement of scalpel blades may be a better alternative than using safety scalpels.

In 2011, the magazine Outpatient Surgery and the International Sharps Injury Prevention Society surveyed 186 operating room clinicians and found that 60% of respondents were not using safety scalpels at their hospitals. OSHA is not fining many institutions since 95% of those who answered said they had never been fined.

Meanwhile, safety scalpel use is far less than expected. The use of safety scalpels appears to have been based on an unwarranted assumption that safety scalpels are safer.

It is certainly possible that safety scalpels do reduce the incidence of injuries, but it is equally possible that the rate of injuries in the same or even worse with the use of safety scalpels.

As a byproduct of their investigation, the authors mention that the use of hands free passing techniques for sharps, double-gloving and avoidance of using hands as retractors have been shown to be effective in reducing sharps-related injuries.

But not safety scalpels. So why are they being used at all?

Friday, November 8, 2013

Sleep deprivation, surgeons, operations, and outcomes

A new paper found that surgeons who performed elective laparoscopic cholecystectomies after having operated the night before had outcomes similar to those when they were presumably well-rested.

The retrospective study involved 331 surgeons who did 2078 cholecystectomies after operating the night before and 8,312 when not operating the night before. Outcomes both were matched for each surgeon.

Comparing outcomes after operating the night before to not found rates of conversion to open - 2.2% vs. 1.9%, risk of iatrogenic injuries - 0.7% vs. 0.9%, and death - 0.2% vs. 0.1%, respectively. None of those differences were significant.

The abstract concluded, "These findings do not support safety concerns related to surgeons operating the night before performing elective surgery."

This paper is the latest of several that show similar results.

So case closed, right?

As much as I hate to say this, the paper does not prove that sleep deprived surgeons don't have more complications than when they are well rested. What it does prove is that conversion rates, not complication rates, are the same whether the surgeon got adequate sleep the night before or not.

In the paper, which was published in JAMA, the authors said, "Although not always considered a complication, conversion to open cholecystectomy may serve as an aggregate end point for many complications."

I disagree. I know of no previous study confirming that conversion of a laparoscopic cholecystectomy to an open procedure is a marker for complications. Instead, I believe it is a sign of good judgment. The sooner a surgeon recognizes that he can't safely do the procedure laparoscopically, the better off the patient is. A surgeon should never be discouraged from converting a case to open.

The study probably included enough patients to support its conclusion that there is no difference in conversion rates, but it is underpowered to detect a difference in iatrogenic injury rates or mortality because those events are so infrequent. To conclude that there is no difference in iatrogenic injury or mortality rates is what is known in statistical circles as a "Type II error" or failure to reject a false null hypothesis. The two null hypotheses in this situation were that there is no difference in 1) iatrogenic injury or 2) mortality rates when surgeons are rested or not.

In other words, the rates of iatrogenic injuries and deaths may not really be different, but the lack of a difference could simply be due to the fact that there were not enough subjects in the study. Iatrogenic injuries and deaths occur so infrequently with laparoscopic cholecystectomy that a study would need a lot more patients in each group to conclude that sleep is not a factor.

Most media coverage of the paper did not question its findings. Even Atul Gawande was hooked. Yesterday he tweeted "New @jama study of daytime surgery by surgeons who operated during night before: found NO increased complications."

Better studies on the effects of sleep deprivation on surgeon performance are needed before the issue is settled.