Association Between Diffusion of the Surgical Robot and Radical Prostatectomy Rates

[gdpawel]

Buy robots and the surgery will be done. A paper in the journal Medical Care concludes that hospitals that acquire surgical robots do more radical prostatectomies as a result (an average of 29% more per year) while those without robots actually did fewer radical prostatectomies.

Association Between Diffusion of the Surgical Robot and Radical Prostatectomy Rates

doi: 10.1087/MLR.0b013e318202adb9

Abstract

BACKGROUND: Despite its expense and controversy surrounding its benefit, the surgical robot has been widely adopted for the treatment of prostate cancer.

OBJECTIVES: To determine the relationship between surgical robot acquisition and changes in volume of radical prostatectomy (RP) at the regional and hospital levels.

RESEARCH DESIGN: Retrospective cohort study.

SUBJECTS: Men undergoing RP for prostate cancer at nonfederal, community hospitals located in the states of Arizona, Florida, Maryland, North Carolina, New York, New Jersey, and Washington.

MEASURES: Change in number of RPs at the regional and hospital levels before (2001) and after (2005) dissemination of the surgical robot.

RESULTS: Combining data from the Healthcare Cost and Utilization Project State Inpatient Databases 2001 and 2005 with the 2005 American Hospital Association Survey and publicly available data on robot acquisition, we identified 554 hospitals in 71 hospital referral regions (HRR). The total RPs decreased from 14,801 to 14,420 during the study period. Thirty six (51%) HRRs had at least 1 hospital with a surgical robot by 2005; 67 (12%) hospitals acquired at least 1 surgical robot. Adjusted, clustered generalized estimating equations analysis demonstrated that HRRs with greater numbers ofhospitals acquiring robots had higher increases in RPs than HRRsacquiring none (mean changes in RPs for HRRs with 9, 4, 3, 2, 1, and 0 are 414.9, 189.6, 106.6, 14.7, -11.3, and -41.2; P<0.0001). Hospitals acquiring surgical robots increased RPs by amean of 29.1 per year, while those without robots experienced a mean change of -4.8, P<0.0001.

CONCLUSIONS: Surgical robot acquisition is associated with increased numbers of RPs at the regional and hospital levels. Policy makers must recognize the intimate association between technology diffusion and procedure utilization when approving costly new medical devices with unproven benefit.

Note. In a news release, the lead author said:

"The use of the surgical robot to treat prostate cancer is an instructive example of an expensive medical technology becoming rapidly adopted without clear proof of its benefit," said Danil V. Makarov, MD, MHS, assistant professor, Department of Urology at NYU Langone Medical Center and assistant professor of Health Policy at NYU Wagner School of Public Health. "Policymakers must carefully consider what the added-value is of costly new medical devices, because, once approved, they will most certainly be used."

"Patients should be aware that if they seek care at a hospital with a new piece of surgical technology, they may be more likely to have surgery and should inquire about its risks as well as its benefits," said Dr. Makarov. "Hospitals administrators should also consider that new technology may increase surgical volume, but this increase may not be sufficient to compensate for its cost."

[url]http://journals.lww.com/lww-medicalcare/Abstract/publishahead/The_Association_Between_Diffusion_of_the_Surgical/99621.aspx

[gdpawel]

According to a Dr. Craig D. Turner Bloomberg Opinion, the decision to opt for medical care that relies on the most costly technology is often based on blind faith that newer, elaborate and expensive must be better.

The sentiment is understandable. We look to the miracles of medical technology to solve all sorts of problems, from weight loss to wrinkle removal. We place even greater faith in this technology when engaged in life’s inevitable losing battle against disease and death.

So exalted is medical technology that it has become our de facto God during times of personal health crisis. Considerations about costs fly out the window. Risks are downplayed or ignored.

Hospitals and physicians are perhaps even more susceptible than the lay public to the allure of new medical technology. Competitive market pressures and our enduring hope that somehow the latest, greatest and best will help us beat the odds combine to create an environment that, at its worst, can foster irrational and ill-considered decisions.

We seem to be promoting newer technology even in the absence of data. Exciting cutting-edge treatments are marketed with the singular effect of peddling hope to patients when they are at their most vulnerable. Rival hospitals and physicians afraid of losing revenue respond by escalating the medical arms race, buying more and more expensive new technology.

Once purchased, the pressure to use this new equipment becomes overwhelming. A procedure accomplished perfectly well -- maybe even better -- with older technology is shoved aside.

One health-care administrator told me the basement of the hospital is full of million-dollar machines collecting dust -- not because they didn’t work or because they were ineffective, but because they have been displaced by newer technology.

All of this spending, which in part explains why the U.S. has the world’s most costly health-care system, takes place while the country ranks 46th in infant mortality and 36th in longevity -- tied with Cuba, according to the United Nations.

To be sure, technological advances have on the whole brought undeniable benefits to health care. The list is long, from the invention of antibiotics to the development of anesthesia.

What is different with the new wave of technological marvels is that many are heavily driven by marketing, require that physicians master arduous new skills and often lack clear benefits compared with established and less-costly technology.

Now 10 years into surgical practice, I have learned some hard lessons related to new equipment and techniques. For one, patients often are put at greater risk as we physicians scale the learning curve.

But put aside for a moment that costs increase when the doctor isn’t familiar with the technology. More things can go wrong.

Costly Robots

The most telling case in point is that of robotics used for surgery. They are costly and require significant re-training for surgeons. Yet consumers hungrily seek out surgeons versed in their use. If a surgeon recommends an older, less expensive technology, many patients will shop for a surgeon willing to use the newest and costliest devices, even if the added benefits are unproven and the risks may be greater.

Hospitals do nothing to discourage this and engage in the kind of tawdry marketing more familiar on late-night infomercials by using patient testimonials. “I cannot believe how quickly I recovered,” a vigorous-looking patient is quoted as saying.

As a surgeon I have to ask: Where is the data? Was the recovery any quicker than in a procedure done without a robot? Would another surgical approach have served the patient as well? And cost a lot less?

Da Vinci

I have been using a robot known as da Vinci, made by Intuitive Surgical Inc. (ISRG), since 2004. The system was developed with funding from the U.S. Army with the main goal of allowing the surgeon to operate through telepresence at a safe distance from a wounded soldier on the battle field.

In a hospital setting, the surgeon sits in the corner of the room at a master console looking into a 3-D virtual view of the surgical field. Hand movements of the surgeon are translated to the robotic arms at the bedside a few feet away. This disconnect of surgeon from patient comes with a $2 million price tag (for the robot) and costs $2,000 to $3,000 each time the device is used.

I try to tell my patients there is no conclusive data aside from reduced blood loss to show the da Vinci is significantly better than open surgery. Furthermore the reduced blood loss is most likely secondary to the machine’s laparoscopic approach, in which one or several tubes are inserted into the body, letting the surgeon see and operate, rather than the benefits of the robot itself.

Prostate Cancer

For example, in using the da Vinci for removal of the prostate in cancer patients, there is no consensus in the data that it provides any improvement in post-operative potency or urine control compared with standard laparoscopy or even larger incision surgery. There has even been some data to suggest cancer control can be compromised with robotic surgery.

But when I tell prospective patients and their families that I plan to use a robot, more often than not they grow wide- eyed and awe-struck.

Lost in the discussion is that I have actually become dependent on the da Vinci. My skills with standard laparoscopy have suffered to the point that I am now reliant on the robot to assist me in performing some of the finer movements of the surgery. Rather than being viewed as incompetent, though, I am seen as the priest who, imbued with the power of robot, will deliver the patient from the shadow of death.

‘My Own Pocket’

When done correctly, innovation should make things more cost-effective and safer while ensuring better results. There are always ramp-up costs and physician-learning curves to consider, and therefore we must use only the most appropriate innovative technology and use it wisely.

We are all keepers of the health-care system treasury. In making treatment choices, physicians and patients alike would do well to ask: “If I were paying for this out of my own pocket would I choose this treatment, or am I just being wowed by the cool factor at someone else’s expense?”

In the first decade of practice I was enthralled with the amazing new technology. Moving into my second decade I hope to temper some of that enthusiasm with a bit of good old-fashioned fiscal responsibility.

(Craig D. Turner practices urology in Portland, Oregon, and is founder of medical device company ETHOS Surgical.)

A large number of adverse events in surgeries involving robotic surgery have been reported to the FDA, available in a database assembled at the Citron Research Website run by short seller Andrew Left.

[url]http://www.citronresearch.com/wp-content/uploads/2013/01/Intuitive-Surgical-part-two-final.pdf

[gdpawel]

A paper published in the Journal for Healthcare Quality examined the content of information on 400 randomly selected U.S. hospital websites about robotic surgery. Forty-one percent of hospital websites described robotic surgery. Among these, 37% percent presented robotic surgery on their homepage, 73% used manufacturer-provided stock images or text, and 33% linked to a manufacturer website. Statements of clinical superiority were made on 86% of websites, with 32% describing improved cancer control, and 2% described a reference group. No hospital website mentioned risks. Materials provided by hospitals regarding the surgical robot overestimate benefits, largely ignore risks and are strongly influenced by the manufacturer.

ScienceDaily reports, "The public regards a hospital's official website as an authoritative source of medical information in the voice of a physician," says Marty Makary, M.D., M.P.H., an associate professor of surgery at the Johns Hopkins University School of Medicine and the study's leader. "But in this case, hospitals have outsourced patient education content to the device manufacturer, allowing industry to make claims that are unsubstantiated by the literature. It's dishonest and it's misleading."

In the last four years, Makary says, the use of robotics to perform minimally invasive gynecological, heart and prostate surgeries and other types of common procedures has grown 400 percent. Proponents say robot-assisted operations use smaller incisions, are more precise and result in less pain and shorter hospital stays -- claims the study's authors challenge as unsubstantiated. More hospitals are buying the expensive new equipment and many use aggressive advertising to lure patients who want to be treated with what they think is the latest and greatest in medical technology, Makary notes.

But Makary says there are no randomized, controlled studies showing patient benefit in robotic surgery. "New doesn't always mean better," he says, adding that robotic surgeries take more time, keep patients under anesthesia longer and are more costly.
None of that is apparent in reading hospital websites that promote its use, he says. For example he points out that 33 percent of hospital websites that make robot claims say that the device yields better cancer outcomes -- a notion he points out as misleading to a vulnerable cancer population seeking out the best care.

When describing robotic surgery, the researchers found that 89 percent made a statement of clinical superiority over more conventional surgeries, the most common being less pain (85 percent), shorter recovery (86 percent), less scarring (80 percent) and less blood loss (78 percent). Thirty-two percent made a statement of improved cancer outcome. None mentioned any risks.

"This is a really scary trend," Makary says. "We're allowing industry to speak on behalf of hospitals and make unsubstantiated claims."

Makary says websites do not make clear how institutions or physicians arrived at their claims of the robot's superiority, or what kinds of comparisons are being made. "Was robotic surgery being compared to the standard of care, which is laparoscopic surgery," Makary asks, "or to 'open' surgery, which is an irrelevant comparison because robots are only used in cases when minimally invasive techniques are called for."

Makary says the use of manufacturer-provided images and text also raises serious conflict- of-interest questions. He says hospitals should police themselves in order not to misinform patients. Johns Hopkins Medicine, for example, forbids the use of industry-provided content on its websites.

"Hospitals need to be more conscientious of their role as trusted medical advisers and ensure that information provided on their websites represents the best available evidence," he says. "Otherwise, it's a violation of the public trust."

Journal for Healthcare Quality, 2011; DOI: 10.1111/j.1945-1474.2011.00148.x

[url]http://www.sciencedaily.com/releases/2011/05/110518092040.htm

A paper in Health Affairs – “Direct-To-Consumer Internet Promotion Of Robotic Prostatectomy Exhibits Varying Quality Of Information” (subscription required) – adds to mounting questions about the marketing and promotion of this technology.

A team of researchers analyzed claims made in online promotions of robotic surgery for prostate cancer. Excerpts of the paper:

“We found that many sites claimed benefits that were unsupported by evidence and that 42 percent of the sites failed to mention risks. Most sites were published by hospitals and physicians, which the public may regard as more objective than pages published by manufacturers. Unbalanced information may inappropriately raise patients’ expectations. Increasing enforcement and regulation of online promotions may be beyond the capabilities of federal authorities. Thus, the most feasible solution may be for the government and medical societies to promote the production of balanced educational material.

Many people probably understand that they should not put stock in health information found on user-generated websites. However, it is not as obvious that sites published by members of the medical community may also be subject to concerns about quality, completeness, and bias. Although these publishers may have conflicts of interest, their public reputation and medical background may imply to many people that they are balanced and objective.

Overall, there was a wide range in the tone and presentation of the web pages we reviewed. Some pages used a direct, informational tone; others used excessively ornate prose about the wonders of life without cancer, with fairly little substantiative discussion of robotic prostatectomy. One site directly stated that there were no risks associated with robotic prostatectomy, then proceeded to list a number of risks lower on the page. We found information of poor quality presented on many sites in our sample, not just those that might be considered outright advertising.

As advertising shifts from traditional media to the Internet, the regulation of advertising content becomes increasingly difficult. The amount of print and broadcast advertising is limited by the high cost of these media. In contrast, Internet promotion expands the opportunities for inexpensive, direct-to-consumer marketing. Thus, the volume of material promoting specific medical procedures, devices, and drugs may be impossible for any single entity to monitor. Proposals to increase regulation of direct-to-consumer medical care promotion may also be limited by legal and ethical considerations associated with restricting free speech.

Instead of creating new regulations and strengthening enforcement, it may be more feasible for the FDA and medical societies to promote the creation of responsible, balanced educational material. These organizations could produce and distribute guidelines intended for physicians and hospitals that describe how to develop educational materials in a balanced and patient-friendly manner. Additionally, specialty societies could provide template descriptions of risks and benefits to help doctors describe the medical products and procedures they use.”

http://content.healthaffairs.org/content/31/4/760.full

[gdpawel]

Dr. Herman Kattlove

The Robotic surgery is done with a Da Vinci Robotic device that actually does the cutting while the surgeon twiddles the knobs. One virtue is that recovery time is shorter versus standard surgery. But the big questions are whether one can control his urine normally after the surgery and whether one can have normal sex.

Here are the data, published in the February 10, 2012 issue of the Journal of Clinical Oncology. The authors, from Boston and Hanover, NH questioned nearly 800 Medicare-insured men who had one or the other of the procedures for prostate cancer. They asked whether they had any problem with urinary incontinence and how was their sex life.

These men were generally in good health so health issues weren’t a problem. But their urinary tract was a problem for about half the men who had the standard operation and 60 percent of those who had the robotic procedure. About 10 percent of the men in each group said they had big problems. This usually means leaking urine – treated with absorbent underwear or diapers or both.

The numbers were even less encouraging when it came to the sex life of these men. Almost none of them said “no problem,” while nearly 70 percent in both groups said “big problem” meaning they were likely impotent – couldn’t get an erection. And, unfortunately, experience has shown that Viagra doesn’t help in this situation. So it is clear that although men will get out of the hospital quicker with the robotic procedure - a good thing - the end results are no better.

There is a learning curve with the robotic procedure. After all, working through a small opening in the body with dials, is totally different than the usual surgery. This occurred when laparoscopic surgery was first introduced – lots of misadventures by formerly fine surgeons.

Now, with new surgeons brought up on video games and familiar with robotics, the procedure may become less damaging. Some studies from some hospitals have shown the robotic procedure better, perhaps because they had a super robotic surgeon but for the average patient that kind of information is nearly impossible to get.

And then of course there is the whole subject of whether most prostate cancers need treatment. We still don’t know for sure, so more operations than necessary are done, particularly in younger men.

Of course, the good news is that younger men will do better with either procedure, whether they need it or not and all may do better as surgeons get more experience. Time will tell.

[Dr. Kattlove is a retired medical oncologist who was medical editor for the American Cancer Society where he helped develop much of the information about specific cancers that is posted on the society's website. From his private blog]

[gdpawel]

Adverse Effects of Robotic-Assisted Laparoscopic Versus Open Retropubic Radical Prostatectomy Among a Nationwide Random Sample of Medicare-Age Men

Michael J. Barry 1, 3, Patricia M. Gallagher 2, Jonathan S. Skinner 4, and Floyd J. Fowler Jr 2, 3

1. Massachusetts General Hospital
2. University of Massachusetts
3. Foundation for Informed Medical Decision Making, Boston, MA
4. Dartmouth College and The Dartmouth Institute for Health Policy & Clinical Practice, Hanover, NH.

Abstract

Purpose:

Robotic-assisted laparoscopic radical prostatectomy is eclipsing open radical prostatectomy among men with clinically localized prostate cancer. The objective of this study was to compare the risks of problems with continence and sexual function following these procedures among Medicare-age men.

Patients and Methods:

A population-based random sample was drawn from the 20% Medicare claims files for August 1, 2008, through December 31, 2008. Participants had hospital and physician claims for radical prostatectomy and diagnostic codes for prostate cancer and reported undergoing either a robotic or open surgery. They received a mail survey that included self-ratings of problems with continence and sexual function a median of 14 months postoperatively.

Results:

Completed surveys were obtained from 685 (86%) of 797 eligible participants, and 406 and 220 patients reported having had robotic or open surgery, respectively. Overall, 189 (31.1%; 95% CI, 27.5% to 34.8%) of 607 men reported having a moderate or big problem with continence, and 522 (88.0%; 95% CI, 85.4% to 90.6%) of 593 men reported having a moderate or big problem with sexual function. In logistic regression models predicting the log odds of a moderate or big problem with postoperative continence and adjusting for age and educational level, robotic prostatectomy was associated with a nonsignificant trend toward greater problems with continence (odds ratio [OR] 1.41; 95% CI, 0.97 to 2.05). Robotic prostatectomy was not associated with greater problems with sexual function (OR, 0.87; 95% CI, 0.51 to 1.49).

Conclusion:

Risks of problems with continence and sexual function are high after both procedures. Medicare-age men should not expect fewer adverse effects following robotic prostatectomy.

Supported by Grant No. 2 P01 AG019783-08 from the National Institute on Aging.

JCO February 10, 2012 vol. 30 no. 5 513-518

[url]http://jco.ascopubs.org/content/30/5/513.abstract

“However, whether these advantages justify the significantly higher costs of robotic technology remains to be seen. Most notably, the robot is a tool, and tools are only as good as the surgeons who wield them.”

Current Urology Reports April 2013 Does Robotic Prostatectomy Meet Its Promise in the Management of Prostate Cancer? Kuo-How Huang, Stacey C. Carter, Jim C. Hu

FDA Investigating Potential Problems with Popular Surgical Robot

[url]http://healthland.time.com/2013/04/09/fda-investigating-potential-problems-with-popular-surgical-robot/