Thursday, March 28, 2013

Surgical smoke: Is it dangerous to your health?


An operating room nurse from the UK has asked me to comment on the burning issue of surgical smoke. [Pun intended.] I don’t think she’s going to like what I have to say.

For several years, studies have found that all kinds of chemicals and organic bits can be found in smoke plumes generated by electrocautery and lasers in the operating room. Some of the chemicals are said to be carcinogens and the organic material reportedly contains intact viral genetic material.

Many organizations have called for the establishment of government regulations regarding the amount of stuff that should be allowable in OR smoke. However, OSHA has been surprisingly reluctant to do anything and has not officially commented on the subject since 1996. The OSHA website does say that about half of the states have various regulations in place.

Some groups, particularly nursing organizations, are calling for the placement of smoke evacuators in all operating rooms. As you might suspect, these efforts are being vigorously supported by the manufacturers of smoke evacuators.

I attempted to find some real evidence about all this, but it is hard to come by. There have been no randomized trials involving surgical smoke.

A very interesting presentation by a group from the Centre Hospitalier Universitaire de Québec (CHUQ) at the 2011 Cochrane Canada Symposium addressed the subject in a health technology assessment.

For biologic and chemical substances, the CHUQ health technology assessment said the risks of transmission of diseases were unclear.

They measured the air in operating rooms and said, “[A]mbient air concentrations of carbon monoxide, volatile organic compounds, and particulate matter are very low and far below the occupational exposure limits.”

They concluded, “There is no clear evidence that surgical smoke may represent health hazard,” but hedged by saying that smoke evacuators should be restricted to specific types of cases such as breast surgery. They offered no evidence to support that recommendation.

There are only two case reports in the literature claiming transmission of viruses in surgical smoke from patients to healthcare workers. These case reports are frequently cited by advocates of smoke evacuation devices.

The first case report, cited in PubMed 16 times but many more times in other documents, is from Norway. Here is the complete abstract. I added emphasis in bold.

A 44-year-old laser surgeon presented with laryngeal papillomatosis. In situ DNA hybridization of tissue from these tumors revealed human papillomavirus DNA types 6 and 11. Past history revealed that the surgeon had given laser therapy to patients with anogenital condylomas, which are known to harbor the same viral types. These findings suggest that the papillomas in our patient may have been caused by inhaled virus particles present in the laser plume.

The second case report, cited 3 times, is from Germany. Here is its abstract.

A 28-year-old gynecological operating room nurse, who assisted repeatedly in electrosurgical and laser surgical excisions of anogenital condylomas, developed a recurrent and histologically proven laryngeal papillomatosis. The expert opinion of a virological institute confirmed a high probability of correlation between the occupational exposition and the laryngeal papillomatosis so that it was accepted as occupational disease. HPV-DNA has been repeatedly detected in laser-plume after excision of papillomas and condylomas. As of the present an exact proof that these particles are infectious has not been brought forward.

There are other ways to acquire HPV virus in one’s throat.

The CDC reports that 48 million inpatient operations were performed in the United States in 2009. In the last 25 years, not a single case of proven (or unproven) transmission of any disease by surgical smoke has been diagnosed. Had such a case been found, it no doubt would have made headlines.

The Anesthesia Quality Institute estimates that there are 35,000-45,000 operating rooms in the United States. A smoke evacuation machine costs a minimum of $1000, not including the costs of disposable tubing for every case and filters which need periodic replacement.

Let’s say 40,000 ORs X $1000/smoke evacuator = $40,000,000 to prevent exactly zero cases of disease. This does not take into account the costs of disposable tubing.

In these economic times, can anyone think of a better place to spend $40,000,000?


Wednesday, March 27, 2013

Staying ahead of the news: Why you should follow Skeptical Scalpel

During the last three months, seven stories have appeared on major news or medical sites well after I had blogged about them. Here they are.

“Why Failing Med Students Don’t Get Failing Grades” was published in the New York Times on February 28, 2013. I blogged about this subject and why med school is like T-ball (everyone gets a trophy) on October 17, 2012. Links are here: Times/Me
 
On February 24, 2013 an article called “‘Bloodless’ Lung Transplants Offer Hint at Surgery’s Future” appeared in the New York Times. The need to reduce blood transfusions was the subject of a blog on February 4, 2013, 20 days earlier. Times/Me

The Wall Street Journal ran “Study Raises Doubts Over Robotic Surgery” on February 19, 2013 and on February 21, 2013, The Atlantic's version was “Robots taking a record number of human uteri.” They both discussed a paper appearing in JAMA that week on the failure of robotic hysterectomy to show improved outcomes for benign disease. I had published 15 blogs about the shortcomings of robotic surgery prior to that date. WSJ/Atlantic/My blog (Search “robot”)

Intensive care MDs: More white coats, fewer piercings preferred” was in the Los Angeles Times on February 19, 2013. I explained why I wear a white coat way back in July of 2012. Times/Me

New York Times wrote about declining law school admissions and fewer jobs for lawyers on January 30, 2013. I addressed these issues on January 7, 2013. Times/Me

In the January 23/30, 2013 issue of JAMA, an editorial the problems associated with using 30-day readmissions as a quality indicator. I dealt with this in early October of 2012. JAMA/Me

This one was at least close. Bill Keller's January 27, 2013 opinion piece in the New York Times on why pay-for-performance for doctors won't work was only three days behind my blog on the subject. Times/Me






Monday, March 25, 2013

Misleading headline of the month: “Weekend worse for surgery”

“Emergency surgeries performed on a weekend may have poorer results than the same operation performed on a weekday, a new study concludes,” says an article in the New York Times.

However, the statement is not true.

First of all, it implies that all operations done on weekends have poorer results by failing to mention the fact that the study that found this result only concerned patients with inflammatory bowel disease (IBD)—that is, ulcerative colitis and Crohn's disease.  And although the paper looked at both types of IBD, only patients with ulcerative colitis were found to have significantly different outcomes based on day of admission.

Second and most important, the paper's significant result was that patients who were admitted on weekend days had worse results. On page 6 of the paper (the full text of which is available online), the authors state, “Hospitalisation [sic, the journal is from the UK] day of surgery did not influence post-operative outcomes.”

To recap. What the paper really says it that for one type of IBD, ulcerative colitis, admission to the hospital on a weekend day, not necessarily the day the surgery took place, is associated with a significant increase in mechanical wound complications (I assume they mean wound dehiscence or “burst” wound) and need for repeat laparotomy.

Some limitations of the study are as follows:

  • It is a retrospective review of an administrative, not a clinical database.
  • There was no information about the surgeons or other physicians in the database.
  • It is quite possible that by chance more patients in the weekend admission group were on corticosteroids, which are known to have a negative effect on wound healing.
  • The authors admit that “Unmeasured confounders beyond what we were able to capture in our study could also influence the estimates.”
  • It is not surprising that rates of wound dehiscence and need for repeat laparotomy would both increased since the former begets the latter.
  • The authors could not explain why wound problems occurred in ulcerative colitis but not Crohn's disease patients, nor could they explain what mechanism could lead to the adverse outcomes they found.

There is a plethora of literature on whether or not a “weekend effect” really exists. The Times article would have been better if in addition to getting the facts straight, some balance had been offered. 
 
A brief PubMed search reveals that patients admitted with strokes on weekends fare worse or do not fare worse according to which study you read. Similarly, patients with upper gastrointestinal bleeding fare worse or do not fare worse if admitted on weekends. Take your pick.

The times article concludes with a quote from the lead author, “If you need surgery, you should get it.”

That is the one part of the article I can agree with.

Medical television hits a new low

Tipped off by a reader, I watched “Married to Medicine,” a reality program about doctors' wives and female doctors in Atlanta, which premiered on the cable network Bravo last night.

What a colossal embarrassment to the medical profession, women, black people, television and humanity.

In the beginning, some “highlights” were shown, which featured a pushing match between two of the characters. I should have stopped right there, but regrettably, I kept watching.

I hope the cast members were paid well because they could not have looked worse had they been on Jerry Springer.

What could they have been thinking?

They were portrayed as shallow, materialistic caricatures. And their husbands, the doctors, looked like fools. Two of them were emergency medicine physicians whose practices probably won't suffer. But the orthopedic surgeon—who would go to him after hearing his wife say surgeons bring home the cash?

After about five minutes, I couldn't take it any longer.

The reviews of the show have been mixed. But the New York Times, an organization that should know better actually had a favorable slant. Its reviewer said, A confederation of mostly black women, some of them doctors’ wives and some of them doctors, enacts scenes of petty jealousy and scorched-earth class warfare that reinforce every pernicious cliché about female treachery and the shallowness of buppie culture and that are also, as it happens, reliably entertaining. 

Entertaining if you are a moron.

Black women of Howard University Medical School, who petitioned the network to cancel the show before it ever aired, have different views.

Comments on the petition's website at Change.org were decidedly negative. Here are some excerpts:

Another show depicting black women as shallow, angry, weave wearing, sassy women that can't get along with each other. The bigger issue here is that they are representing a serious community of professionals that have to fight really hard to be taken serious by their white peers.

As a young black woman in the medical field, I was excited about the show, foolishly thinking there would be some sort of mention of, well...medicine. Instead I was incredibly disappointed, disheartened & embarrassed for what I saw. It was a mockery of medicine, and a modern day minstrel show.

This show is not reality! I have many friends that are African American female physicians and I am also married to a surgeon and we are both African American. This is NOT how we live and this is NOT our reality! This is a very negative image and against ALL that we stand for.

Sadly, the petition has only a little over 2000 signatures.

The good news is that one can simply choose not to watch.

Friday, March 22, 2013

Unbelievable Wisconsin Supreme Court ruling on informed consent

I normally wouldn't do this but you need to see excerpts from an article in the Wisconsin State Journal to understand the nature of this case. I have abridged as much as possible.

Thomas Jandre was driving to a job site when the left side of his face started drooping. He began drooling, his speech became slurred and he felt dizzy and weak in his legs.

He went to the emergency room at St. Joseph’s Hospital in West Bend. Dr. Therese Bullis did a physical exam to rule out a stroke. She ordered a CT scan to rule out a hemorrhagic stroke, or bleeding in the brain. To check for an ischemic stroke, from a clot, she used a stethoscope to listen for unusual blood flow in his carotid artery. She diagnosed Jandre with Bell’s palsy, inflammation of a nerve that controls facial movement.

Eleven days later, Jandre had a massive stroke that caused permanent damage to the left side of his body. An ultrasound showed the carotid artery along his neck was 95 percent blocked.

Bullis was negligent in not telling Jandre he could have had a carotid ultrasound when she saw him, the Wisconsin Supreme Court ruled in April. The test might have led to treatments to prevent the stroke.

The supreme court affirmed an appeals court decision that upheld a $2 million jury award in 2008 to Jandre, now 57, whose stroke occurred in 2003. The jury said Bullis wasn’t negligent in her diagnosis of Bell’s palsy but found her negligent in her duty of informed consent because she failed to discuss the carotid ultrasound.

The decision “leaves physicians in the difficult position of not knowing how much information a physician should provide to a patient about tests for diagnoses already ruled out by the physician,” said a statement by three Wisconsin MD organizations.

The groups said the decision could drive up health care costs by requiring unnecessary tests. They’re calling for state legislation to clarify informed consent.

But Dr. Sheldon Wasserman, chairman of the state Medical Examining Board, said he agrees with the ruling. “You should give patients all the information they need and more,” he said.

Jim Weis, the Wausau attorney who represented Jandre, said if Bullis had conducted a “one-minute conversation” with Jandre about the ultrasound, “the stroke would have been avoided.”

A second article noted that the doctor was reprimanded by the state medical board and fined $300. It also says that the state legislature may introduce a bill to clarify the informed consent law.


Wow! I agree that the ED physician was not negligent in arriving at the wrong diagnosis. That can happen. It's not negligence if you do everything right and come up with the wrong answer. According to the courts, her “negligence” was in not telling the patient that a carotid ultrasound could have been done.

Just how would a “one-minute conversation” with the patient have avoided the stroke? Would the patient then have had the option to demand the test? If that is so, why not skip the history and physical examination by the doctor altogether and let the patient choose from an a la carte menu of diagnostic tests when he comes through the door?

This case opens up a huge can of worms. Should all patients who are determined by an ED MD to not have appendicitis be told that they could have a CT scan and if that is negative, an ultrasound? Might as well throw in an MRI too, even though it has never been proven to be useful for that illness.

And who believes that the state legislature will solve the problem of informed consent brought up by this case? Not I.

If you think healthcare is expensive now, wait until the emergency medicine community gets wind of this case.

Wednesday, March 20, 2013

Robotic surgery controversies simmer

I'm involved in a protracted and good-natured (I hope) debate about the merits of robotic surgery with a University of Pittsburgh urologist named Ben Davies. Today he tweeted the following (with translation for the Twitter averse):

“I would love for a $ISRG [stock symbol for Intuitive, makers of the robot] MD hater (like @Skepticscalpel) to actually watch 10 open RRPs [radical retropubic prostatectomies] then watch a 10 robotic RRP. Call me with results”

Dr. Davies is a rabid proponent of robotic prostatectomy and by his own admission, is pretty good at it.

I will admit that robotic surgery may indeed be better than open or standard laparoscopic prostatectomy. There is a lot of level 3 evidence to suggest that.

However, a PubMed search today fails to reveal any randomized trials of robotic vs. open or laparoscopic prostatectomy. All research on this subject has been retrospective with the potential flaws associated with that type of study, selection bias, unknown confounding variables, unblinded authors, etc.

In Australia, randomized study of sorts is in progress comparing 200 robotic prostatectomies done by a single surgeon to 200 open prostatectomies done by a different surgeon. A search of ClinicalTrials.gov yields only one other prospective trial in progress. It is a “medico-economic” one from France. There is a trial about whether or not a drain should be used in robotic prostatectomy which assumes that the issue of whether robotic is better than open or standard laparoscopic is settled.

Dr. Davies has a rather narrow view. Although in his field robotic surgery may prove to be better, there is not even anecdotal evidence that it results in improved outcomes for any other type of surgery. Two major gynecologic organizations have recently issued position papers stating that robotic hysterectomy is not indicated for benign disease.

A number of unusual and often devastating complications of robotic surgery are surfacing, which has prompted one state, Massachusetts, to issue an advisory to hospitals.

Defenders of the robot say it's not the technology itself but rather the surgeons who are at fault.

However, the well-documented intense marketing of the robot by its manufacturer and by hospitals attempting to gain market share is pushing surgeons to adopt the method to stay competitive. The amount of training provided may be inadequate and the learning curve for most procedures is unknown but presumed to be long.

So we have a decidedly more expensive technology which even in its possibly most likely area of success, radical prostatectomy, has never been proven more effective in a well-designed prospective study.

I'm afraid I'm going to have to keep pushing on this.

By the way, I appreciate the offer to watch 20 prostatectomies, but must it be 20? How about 4?

Monday, March 18, 2013

Healing the hospital hierarchy: A different view



The other day, Theresa Brown, an oncology nurse who has somehow finagled a quasi-regular column in the New York Times, wrote about, you guessed it, another unpleasant encounter with a mean doctor.

Her patient was about to undergo a stem-cell transplant when he developed what she called "textbook symptoms of a heart attack." A cardiogram had been done and while awaiting the arrival of a cardiologist (apparently a myocardial infarction can only be ruled out by a cardiologist at her hospital), the patient's doctor, a big bad oncologist, arrived on morning rounds.

He took a quick look at the EKG and said “This does not concern me.” In the hallway, Nurse Brown challenged him in front of his team of doctors and he had the temerity to ask her why in an intimidating way. 

After another 600 or so words about collaboration, blah, blah, teamwork, blah, blah, we come to find that the cardiologist confirmed the oncologist's impression that the EKG did not show a heart attack and the patient went for the procedure.

OK, I'm not saying that doctors don't intimidate nurses. And I'm not saying that it's all right to do so. I realize that some physicians can be annoying, overbearing and even disruptive. I just blogged about this myself today on another site. But was this really the best anecdote that Nurse Brown could come up with about how she rose to the defense of a poor patient?

When I was in practice, I had no problem with nurses questioning my actions if the question was based on a legitimate concern and (this is important) the nurse knew what she was talking about.

Unfortunately, the latter feature was often not present in the discussion. This is because as Nurse Brown points out, "Doctors and nurses are trained differently." 

She also says, "Some nurses reject the whole idea of doctor’s orders; they think the term makes nursing sound subservient." Excuse me? What would be the alternative? Nurses deciding what should be done? Anarchy?

Maybe it would have been better if she had said to the oncologist, "Can I have a word with you in private?" 

How do you think a nurse would feel if I confronted him in front of all of his colleagues at the nurses' station? 

Nurse Brown laments that there are no protocols to resolve disagreements between doctors and nurses. I disagree. Since the overwhelming majority of orders are not of a life-or-death nature, one can simply go up the chain of command. When this has happened to me, I have spoken to the nurse's supervisor to help sort things out. It works in reverse too. The nurse can talk to her boss who can talk to the doctor's chief of service. It's called "communication," one of the very things Nurse Brown says is lacking.

One of the reasons so many doctors are depressed and burnt out is the seemingly endless supply of articles like Nurse Brown's blaming us for everything that is wrong with medical care in the United States.
 

School or Scam? St. Augustine School of Medical Assistants



My blog is being bombarded with spam comments from a purported school called "St. Augustine School of Medical Assistants." Of course, I have not published any of the numerous attempts but I am getting tired of dealing with it. I have reported the person who is trying to post the comments, "m rana," to Google several times but to no avail.

As a public service, I will present what I have found out about this school.


It claims to be accredited, but the alleged accrediting organization, The National Accreditation and Certification Board (NACB), is not recognized by any legitimate medical authority. In fact, it "accredits approved alternative holistic health practitioner programs and certifies graduates of said programs which meet all of the National Accreditation and Certification Board qualifications."


Graduates of St. Augustine School of Medical Assistants are not eligible to sit for the Certified Medical Assistant examination.


Donald A. Balasa, JD, MBA, executive director and legal counsel for the American Association of Medical Assistants, has written about this school saying its ads are misleading and calling it a "diploma mill." [Here is a guide explaining how to spot a diploma mill.]


The St. Augustine School of Medical Assistants appears on a list of " Unauthorized Schools and Invalid Degrees" posted by the State of Oregon. The site says, " The following colleges and universities are not permitted to enroll Oregon students or offer degree programs in Oregon. Degrees from these colleges are not valid in Oregon, and may not be used for academic or employment purposes, or acknowledged as a credential in any public forum or publication, including on a website or in communication related to professional practice or participation in professional organizations."


If you want further information, I suggest you check out a forum on the Indeed.com website detailing several complaints about this school.


Addendum [3/18/13 9:30 a.m.]: I just received notification that "m rana" has posted a comment on this site. I am going to publish it just to prove to you that it's true. I'm not Jewish but I believe they call it "chutzpah."

Friday, March 15, 2013

Let’s do something about the overuse of blood transfusions



Despite the fact that many papers have identified the problem, inappropriate blood transfusions continue in hospitals across the nation.

This topic was featured at the recent Patient Safety Science and Technology Summit that was held in Orange County, California last month.

Transfusion of packed red blood cells is very common. Over 2 million patients or 5.8% to 10% of inpatients are transfused every year with some 15 million units of blood.

There is much variability and inappropriateness in the use of blood transfusions.

A paper in the February 2013 issue of Annals of Surgery reviewed the University Health System Consortium database and the American Hospital Association Annual Survey File for the years 2006-2010. The authors reviewed 54,405 total hip replacements, 21,334 colectomies and 7929 pancreaticoduodenectomies.

Even when adjusted for patient risk factors, hospital-specific transfusion rates ranged from 1.5% to 77.8% for total hip replacement, 1.7% to 49.9% for colectomy and 0% to 90.9% for pancreaticoduodenectomy. Bear in mind that this study involved university hospitals.

A recent survey showed that while medical schools devote an hour or two to lectures about blood, they center on blood typing and compatibility but not on indications. A speaker at the summit pointed out that it is time to start focusing on the safety of patients rather than the safety of blood.

One study showed that only 12% of blood transfusions were appropriate, 59% were inappropriate and opinions were divided about the appropriateness of the remaining 29%.

Here are some important points:

  • Blood transfusion is rarely based on sound evidence because except in trauma patients, there is not much evidence in the literature.
  • Few articles support the premise that transfusion improves outcomes.
  • Blood transfusion has a poor risk-benefit ratio. There are many adverse outcomes such as infection, immunosuppression, transfusion-related acute lung injury, allergic reactions, errors in administration and even death, to name a few.
  • The true cost of a unit of blood is estimated at $500 to $1200, which means that at 15 million units per year, overall costs could be as high as $15 billion. And that is just the cost of the blood itself. It doesn’t include costs of associated complications.
  • Overuse leads to shortages causing patients who might really benefit from a transfusion to not receive it in a timely way.
  • Informed consent discussions rarely mention the risks of transfusion.
  • Many doctors and administrators are not aware of the problem of transfusion overuse.

With a concerted effort, the Cleveland Clinic has decreased the use of transfusions by 30% in the last four years.

The panel discussion at the safety summit concluded the following:

Anemia in patients scheduled for elective surgery should be identified and corrected without transfusion if possible.

In the OR, the decision to transfuse should not be based on a number. To avoid confusion, the trigger to transfuse should be discussed during the pre-operative time-out.

Transfusion should become a quality indicator with physician champions, education of medical staffs, justification of every unit transfused and scorecards for those prescribing blood.

As surgeons, we should be leading the effort to rectify this continuing problem.

A video of the presentation and panel discussion on the overuse of red blood cell transfusions is here.

Disclosure: I attended the Patient Safety Science and Technology Summit thanks to a grant from Masimo who had no input into what is written here.