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.

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?

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?

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.

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?

Should all surgeons have video assessments of their skills?

Last month, a superb study by the Michigan Bariatric Surgery Collaborative showed that the more skilled surgeons were, the better were their outcomes.

Surgeons submitted a video of their choice depicting their performance of a laparoscopic gastric bypass. Since it was self-selected, it was presumably their best work. At least 10 of their peers, blinded as to the name of the surgeon, rated skills on the video which had been edited to include only the key portions of the case.

Surgeons in the lowest quartile of ratings for surgical skill had significantly more postoperative complications, readmissions, reoperations, and deaths.

A New York Times article about the paper features a couple of short video clips—one from a not-so-skilled and one from a very skilled surgeon. The differences are obvious and dramatic.

According to the discussion section of the paper, the Michigan bariatric surgeons are now watching each other operate and will soon be receiving anonymous feedback about their technique from their peers.

It is not clear whether this will improve the skills of the lower-rated surgeons or have any effect on outcomes.

Many people rightfully praised the research. Some suggested that all surgeons should be scrutinized in this same fashion.

I agree that the study was well-done and shows that technically better surgeons have better outcomes.

But there are some problems with generalizing this to all surgeons.

The American Board of Surgery recently noted that there are almost 30,000 board-certified general surgeons in the US. This raises a number of logistical issues.

Let's say we focus on the most common major surgical procedure—laparoscopic cholecystectomy, 10 surgeon-raters would have to view at least 15 to 20 minutes of video for each of the 30,000 board-certified general surgeons. How long would that take? Who would collect and edit all the videos? Who would make sure that the ratings were consistent? Who would collate and distribute the results? How would follow-up be done? Who would pay for all of this?

And that is just for the board-certified general surgeons. What about the general surgeons who are not board-certified and all the other surgical specialists? Maybe gastroenterologists should have their endoscopy procedures scrutinized. Maybe primary care docs should have selected office visits recorded too.

This is similar to the enthusiasm which surrounded the concept of using retired surgeons to coach other surgeons. The idea was based on the experience of one surgeon, who had access to an expert coach and wrote about it. I blogged about the logistical difficulties that would preclude coaching from becoming widespread. To my knowledge in the two years since I wrote that post, coaching has not caught on as a performance improvement measure.

It's too bad, because in an ideal world, video evaluation of operative procedures and coaching would be great. Unfortunately, we don't live in an ideal world.

Shoulder surgery postop follow-up

I'm almost 6 weeks out from my arthroscopic right rotator cuff surgery. Here's my post about the first part of the journey.

I'm feeling much better. I can now remove the sling while I am sitting. It has to be on when I'm walking, and I still have to sleep in it. It's a bulky thing that prevents me from moving and possibly damaging the healing tendon repairs.

Sling selfie

You can see that I can't raise my arm or move it too close or too far from my body.

Tendons are not as sturdy as ligaments, fascia, or even skin, so they must be given a lot of time to heal. Excess active motion could disrupt the repair. That would be bad.

The problem is that the immobilization causes the shoulder to "freeze." It quickly becomes very stiff. At my physical therapy sessions, the therapist passively moves the arm into places the shoulder does not want it to go. Passive motion does not stress the repair. We go for more range of motion at every visit. It hurts. I'm also doing some carefully selected exercises at home every day.

Some funny things have happened. The other night I dreamed I was playing tennis. I was hitting the ball really well, but I kept thinking, "Mary (my wife) is going to kill me if she finds out."

Last night's dream was about me standing in a large group and explaining over and over how I hurt myself, what the surgery was like, how long the recovery will take and on and on.

I don't need Dr. Freud to help me interpret those dreams.

Later on this week, I'll be able to discard the sling and even starting driving again. The physical therapy will continue for a few more months. I hope to be back to full activity by February.