Papers about robotic surgery outcomes may be swayed by payments from the manufacturer

In 2015 alone, the top 20 surgeons receiving payments from Intuitive Surgical Inc., makers of the da Vinci robot, collected a median of almost $142,000. Of those surgeons, 12 have published 37 papers about the robot with 27 (73%) reaching strongly favorable conclusions about the robot’s effect on clinical outcomes, feasibility, or safety. Nine (24%) were equivocal, and one (2%) study was negative.

These results appeared in a paper published online in the American Journal of Surgery by investigators from the University of Michigan.

The 37 papers consisted of 36 observational studies and 1 randomized controlled trial. Robotic surgery patient outcomes were compared to patients operated on in the same institution or by the same surgeon in 11 papers, patients operated on in a different institution or by a different surgeon in 4 studies, to a database in 4, and to previously published papers in 2 instances. No controls or comparisons were used in 16 (43%) papers.

Intuitive Surgical sponsored six of the studies, all of which had positive outcomes.

According to the CMS Open Payments website, compensation received by the top 20 surgeons ranged from $106,176 to $325,164. Among the top 20 earners were 11 general surgeons, 4 colorectal surgeons, 3 thoracic surgeons, and 2 gynecologists.

Three of the 37 papers contained no conflict of interest disclosure statements.

Several limitations of the study were listed. Most journals favor publishing papers with positive results. It may be that surgeons not receiving any industry payments might have published similar numbers of positive studies. The accuracy of the Open Payments site has been questioned but it is the best resource we have currently.

The authors described their paper as a pilot study and called for more research on not only Intuitive’s effect on the medical literature but also the influence of industry in general.

The paper also illustrates the woeful state of research on robotic surgery—a device that has been used on patients for almost 20 years.

We need less research

“We need less research, better research, and research done for the right reasons. Abandoning using the number of publications as a measure of ability would be a start.” Although I have expressed similar sentiments in blog posts [here and here], I didn’t say it. It was written by Douglas Altman, a well-known statistician and researcher who died in June.

Altman made that statement in a 1994 BMJ article entitled “The scandal of poor medical research.” Here we are, 24 years later, and nothing has changed. In fact, thanks to the rise of predatory journals, things are much worse.

Altman lamented research containing flaws such as “the use of inappropriate designs, unrepresentative samples, small samples, incorrect methods of analysis, and faulty interpretation” and felt many poor studies were the result of pressure on researchers to publish.

Some data is better than no data at all

Do you believe that?

I heard it frequently when the infamous Propublica Surgeon Scorecard first appeared three years ago. Back then I blogged about it saying “To me, bad data is worse than no data at all.”

A recent study in BJU International confirmed my thoughts about this type of publicly posted data and identified a previously unreported issue. The paper attempted to determine whether the public was able to accurately interpret statistics used in the Surgeon Scorecard. It turns out they were not very good at it.

Investigators from the Department of Urology at the University of Minnesota surveyed 343 people who attended the Minnesota State Fair in 2016. Those who took the survey had a median age of 48, were 60% female, 80% white, and 60% college educated. Their median annual income was $26,550 with an interquartile range of $22,882-$32,587.

The dark side of academic research

A new study found several senior academic surgeons had published papers in what used to be termed “predatory journals.” The newer, gentler term is “solicited publishing,” but it defines the same pay-to-play, low quality publications.

Surgeons from the University of California, San Diego examined 110 emails sent to the senior author from 29 publishers during a six-week period and early 2017. Nearly all were requesting manuscript submissions. The 29 publishers represented 113 different surgery journals most of which had existed for two years or less. Only 12 were indexed in PubMed, and of the 9 that mentioned a self-reported impact factor, the median was 0.24 which means they had less than one citation per article in the last two years. The median publication fee for the 88 journals posting the information was $755.

Emails from the publishers contained a mean of 9.6 grammatical errors, possibly because more than half had addresses in foreign countries, and of those with US addresses, 30% were residential.