Another chapter in “Surgical Cap Wars”

No one expected the AORN [Association of periOperative Registered Nurses] to meekly accept the conclusion of the paper which found no difference in infection rates when surgeons wore surgical skullcaps or a bouffant-style head coverings.

The AORN recently fired back with a letter to Neurosurgery, the journal that published the paper. It has not yet printed the letter or a response to it by the authors of the paper. I look forward to seeing both.

Meanwhile, Becker’s Infection Control and Clinical Quality revealed some tidbits an article entitled and “AORN experts respond to study on bouffant use and SSI rates.” [SSI = surgical site infection]

The AORN claims that it never mandated the use of bouffant headgear. It merely called for “a clean surgical headcover or hood that confines all hair and completely covers the ears, scalp skin, sideburns, and nape of the neck should be worn” because “hair carries bacteria that could [emphasis mine] cause an SSI.”

Lisa Spruce, the director of evidence-based practice for the AORN, said, “It’s up to the facility to determine what’s the best way to get everyone’s hair covered.” This is rather disingenuous as everyone knows the only way to cover every single hair on the head is to wear a bouffant or a hood.

The AORN did not offer any evidence that hair causes infections. Instead Spruce and the other AORN experts chose to nitpick the Neurosurgery study by pointing out a single scatter plot that showed what they said was a decrease in SSI rates after bouffants were worn.

They claim the figure below indicates fewer infections occurred late in the 13 month period of bouffant usage because it took some time for everyone to comply with bouffant use.

Blue is skullcap. Red is bouffant. Time in months

They offer no proof that adoption of the bouffant took several months. In my experience, when hospitals go from skullcaps to bouffants, the transition is abrupt. On the day the mandate takes effect, skullcaps are no longer available. And by the AORN's logic, one could argue that the plot shows a spike in bouffant-associated SSIs at months 4 and 5 of use.

What about statistical significance? The table directly above the figure they cited clearly shows that there was no significant difference in the SSI rate between the two types of headgear for all operations in the hospital, spine cases, or craniotomy/craniectomy procedures.

Click on table to enlarge it.

In fact if you believe in trends, there were slightly more infections for overall operations and spine cases in the bouffant group.

The AORN wants all hair covered. What about the eyebrows? As I mentioned in a post back in May, an outbreak of SSIs that occurred after some plastic surgery operations in Israel was traced to an organism found in the surgeon’s eyebrows.

Bottom line: If the AORN cannot cite evidence proving that scalp or facial hair causes infections, its experts should do their own research and publish it—otherwise stop damaging the organization’s already marginal credibility.

Thanks to Artiger, a loyal reader of my blog posts, for sending me the link to the Becker's article.

It's time to discuss surgeon headgear again

I received this email last week:

My state has recently banned the time-honored surgical cap,

Timed-honored cap

in favor of the “bouffant” cap.

"Bouffant" is French for "doofus"

I have been wearing the disposable surgical caps for my entire career, and have one of the lowest infection rates of any surgeon at my hospital.

Not only are the bouffant caps uncomfortable, I have now developed a severe allergy to them, making them unwearable. Now they say I must wear a full head/beard cover type cap in order to satisfy their requirements...REALLY? 

Head and beard cover even more uncomfortable than bouffant

I asked the hospital to show me a study that proves that the use of a bouffant cap has ANY advantage at all. Of course they can't, because no such study exists.

More on activity restrictions after surgery

In early January, I blogged about the dearth of evidence about activity restrictions after surgery.

A number of people commented and most agreed that there is little basis for most of the activity restrictions surgeons currently use.

An anonymous reader told me about a 2008 study from Creighton University that generated some interesting data about intra-abdominal pressures associated with some common activities. Here’s a summary of the paper.

What about activity restrictions after surgery?

Although, uncommon, bleeding after surgery is the most common potential post-operative complication. To minimize the chances of this occurring, patients are advised to be as minimally active after surgery as possible. This includes activity restrictions such as:
No bending or heavy lifting
No rigorous exercise or exertion
Do not make important plans in the days immediately following your surgery

The above instructions appear on the website of a medical school department. The operation in question is

A. Cholecystectomy
B. Partial mastectomy
C. Inguinal hernia repair
D. All of the above
E. None of the above

Answer: E. None of the above. While all three of the operations mentioned could have been the subject of these activity restrictions, they were taken from a dermatology service's description of the aftercare of Mohs surgery, which is a way of exercising skin cancers—not exactly major surgery.

This topic was suggested to me by a Twitter follower.



I told him that as far as I knew, there is no evidence basis for any of the activity restrictions we tell patients.

When I was a resident in the early 1970s, we kept patients who underwent inguinal herniorrhaphy in bed for no fewer than five days, and nephrectomy patients were bedbound for a week.

For the former, the theory was that early activity might disrupt the repair—implying that many repairs were tenuous in those days. Regarding nephrectomy, the prevailing wisdom was that the tie or ties on the renal vein could be dislodged by increased pressure in the inferior vena cava from something as trivial as a Valsalva maneuver. Following this logic, we should have prevented nephrectomy patients from coughing or having bowel movements too.

Since then, progress has been made. Hernia patients are discharged on the day of surgery, and nephrectomies are not kept in bed.

What is the definition of "heavy lifting"? It is usually described as lifting more than 10 lbs. Where did that come from? Other than 10 being a nice round number, I can't think of another reason.

A far-from-exhaustive literature search revealed no evidence-based studies and nothing at all pertaining to general surgery.

A 2008 opinion paper suggested that cardiac surgery patients who have excessive limitations on their activities might suffer excessive anxiety and depression leading to poor outcomes. They recommended that patients be given "personalized activity guidelines developed by an exercise specialist to help them resume their presurgical lives."

Activity restrictions after gynecologic surgery are also not evidence-based. A review from the University of Utah found no studies relating postoperative activity and surgical success. A previous survey had found "Depending on the surgery, 88-99% of surgeons restricted lifting for mean of 5–7 weeks (range 1–26 weeks and up to 'forever' [?] after vaginal hysterectomy with vaginal repairs)."

In 2011, an expert panel said patients undergoing laparoscopic supracervical hysterectomy should avoid lifting more than 10 kg, bicycle riding, and vacuum cleaning [?] for two weeks.

At the other extreme is the story of Ryan Callahan, a forward for the Tampa Bay Lightning of the National Hockey League. Last May, he began practicing three days after a laparoscopic appendectomy and played in a playoff game two days later.

To put it mildly, the topic of postoperative activity restrictions is long overdue for prospective study.

Do operating room checklists improve outcomes?

The other day Atul Gawande tweeted the following:

I am not against checklists. When I was a surgical chairman, I implemented and used one in both the operating room and the ICU. They do not add costs and may be helpful.

However, the randomized trial that Gawande referred to does not necessarily settle the issue about whether checklists really do reduce complications and deaths.

The paper, published online in Annals of Surgery [full text here], looked at 5,295 operations done in two Norwegian hospitals. The intervention was a 20-item checklist consisting of three critical steps–the sign in before anesthesia, the timeout before the operation began, and the sign out before the surgeon left the operating room. Using a stepped wedge cluster design, patients were randomized to control or the checklist.

Complications occurred in 19.9% of the control patients and 11.5% in those who got the checklist, a significant difference with p < 0.001.

A look at Table 2 finds that of 27 complications or groups of complications, 14 occurred in significantly fewer patients in the checklist group.

Of the significant 14, a few, such as cardiac or mechanical implant complications, could possibly have been prevented by the implementation of the checklist.

For most of the others, the relationship between the use of a checklist and a post-operative complication is tenuous. How could a checklist possibly prevent technical complications like bleeding requiring transfusion, surgical wound dehiscence, and unintended punctures or lacerations?

Here are a few more of the complications that occurred significantly less frequently in the checklist cohort—urinary tract infection, pneumonia, asthma, pleural effusion, dyspnea, and the nebulous categories of "complications after surgical and medical procedures" and "complications to surgery not classified."

What item on a checklist prevents asthma, UTI or any of those on that list?

Embolism, sepsis, and surgical site infection, three complications one would expect a checklist to impact because of reminders to give prophylactic antibiotics and anticoagulation, did not occur at significantly lower rates in the checklist group.

Even the cardiac complication category is open to question because none of the 5 subcategories (cardiac arrest, arrhythmia, congestive heart failure, acute myocardial infarction) differed significantly between the two groups. Only when the 5 were combined did statistical significance emerge.

In the 300-bed community hospital, checklist use was associated with a significantly lower mortality rate than non-use, 0.2% vs. 1.9% respectively (p = 0.02), but no mortality difference was seen in the 1100-bed tertiary care hospital.

The tertiary care institution enrolled 3,811 patients while the 300-bed hospital contributed 1,083. If more patients had been in the latter group, the difference may have disappeared due to the principle of regression to the mean.

Despite the heightened vigilance associated with an ongoing research project, compliance with checklist use was only 73.4%.

Before you go off on me, I will remind you that I do not oppose checklists. Most things we do in medicine are not based on Class 1 evidence.

Just don't tell me that checklists have been proven to reduce complication rates or save lives.

My blog is now being cited as evidence

That is a scary thought.

Some people on Twitter were questioning the rationale for the UK's "Bare below the Elbows" infection control policy which says that all hospital personnel who are in contact with patients must wear short sleeve shirts, no lab coats, no watches, and no ties.

A medical student from the UK who follows me posted this tweet:

In a recent post on anonymity, I tried to justify my existence by referring to a post that I wrote about CT scans and appendicitis noting that I have received many questions from patients asking for advice. This suggested I had credibility despite using a pseudonym.

But I think being cited as evidence tops any previous attempts to claim that my writings can be trusted.

Here's the med student on how the Brits feel about "Bare below the Elbows:" He said they are ambivalent and in his experience the policy results in "infection control people chasing people round for long sleeves/watches and missing the real problems!"

I told him that we have legions of clipboard carriers in our hospitals too.

He added, "Antibiotic stewardship is a far more pressing issue than length of my sleeves."

That's a pretty astute observation for a medical student to have made.

I thank him for considering my blog post as evidence. If you too want to find evidence, here's a link to that post.

Can I apply to be listed in PubMed?

New guidelines for health care personnel attire are short on evidence

The Society for Healthcare Epidemiology of America (SHEA) guidelines for healthcare workers attire have just been published.

Science Daily led with the headline "New Infection Control Recommendations Could Make White Coats Obsolete," which is rather misleading since the guidelines say no such thing.

I won't reproduce the entire 15-page document here since the full text is available online. But here are some highlights along with my comments.

The guidelines say that facilities may consider adopting a "bare below the elbows" (short sleeves, no watch, no jewelry, no ties) policy. They concede that the incremental infection prevention impact of a BBE approach to inpatient care is unknown but it is probably not harmful. I recently wrote about some comments from a microbiologist in the UK on the possible disadvantages of the BBE mandate already ongoing there.

Despite the Science Daily headline, the guidelines actually say that white coats are acceptable as long as they are removed before contact with patients and are laundered regularly. What constitutes "regularly"? The guideline says In our opinion, white coats worn during patient care should be laundered no less frequently than once a week and when visibly soiled. They discuss the debate about whether patients prefer to see doctors in white coats. I blogged about this a while ago too.

They stayed on the fence about whether clothing worn in the hospital should be laundered professionally or at home and surprisingly, did not recommend prohibiting the wearing of neckties.

The Science Daily story contained some interesting quotes from one of the authors of the guidelines.

"White coats, neckties, and wrist watches can become contaminated and may potentially serve as vehicles to carry germs from one patient to another," said Dr. Mark Rupp, who added, "However, it is unknown whether white coats and neck ties play any real role in transmission of infection," I wonder if he reads my blog?

Dr. Rupp did speculate that sometime in the future if studies show that white coats are harmful, they might disappear to be replaced by scrub suits. That is interesting because the wearing of scrub suits as also been criticized by many.

It's hard to disagree with two of the recommendations:

Appropriately designed studies should be funded and performed to better define the relationship between HCP attire and HAIs [hospital acquired infections].

Until such studies are reported, priority should be placed on evidence-based measures to prevent HAIs (eg, hand hygiene, appropriate device insertion and care, isolation of patients with communicable diseases, environmental disinfection).

But until those studies are done, the guidelines may produce more controversy than compliance.

If I could ask the well-meaning folks at SHEA one question, it would be, "Why issue guidelines if you have no evidence to base them on?"

Evidence-Based Surgery: What Evidence?

Here is a study that illustrates everything that is wrong with the current status of evidence-based surgical practice.

Many of the standard procedures we perform in general surgery are based on observational studies, expert opinion or my favorite “That’s the way I was trained,” and not randomized controlled trials. Although some such research has been done, subjecting patients to sham operations raises ethical issues and would expose patients to anesthesia unnecessarily.

But some topics could be studied prospectively. A recent paper [Variation in the use of intraoperative cholangiography during cholecystectomy. Sheffield KM et al. J Am Coll Surg. 2012;214:668-79] highlights the problem of insufficient evidence in some areas of surgery.

A group from the University of Texas Medical Branch in Galveston looked at differences in the rates of operative cholangiography in their state. They analyzed data from 212 hospitals in which more than 160 cholecystectomies had been done including almost 177,000 such operations over the 8 years from 2001-2008. The surgeon was identifiable in 89% of cases.

Despite the known pitfalls of basing clinical research on administrative data, several interesting findings of this paper are worth discussing.

Operative cholangiograms were done on 44.6% of the total cohort. By hospital, the operative cholangiogram rates ranged from 6.0% to 98.2%. The breakdown by surgeon was limited to the 706 who had done at least 40 cases. The range of operative cholangiogram use by individual surgeons was 0% to 100% with a median of 39%. Medians were higher for patients with gallstone pancreatitis (69%) and lower for those with acute cholecystitis (25%).

Uninsured patients were only slightly less likely to have operative cholangiography than those who were insured. A puzzling finding was that of those patients who had both ERCP and operative cholangiography, 37% had undergone the ERCP before the cholecystectomy and operative cholangiogram. Why would an operative cholangiogram be necessary after an ERCP had already been done?

The authors found that the variation in rates of operative cholangiography was attributed much more strongly to the surgeon and the hospital rather than the indication for surgery. They concluded that the likelihood that a patient would undergo operative cholangiography depended on the hospital she arrived at and who the surgeons was.

The extent of the variation in the use of operative cholangiography could hardly be greater. It is difficult to believe that there is no agreement on the indications. I don’t think this is unique to Texas either.

The literature is conflicting. One can find multiple papers to support any position. Some claim that operative cholangiography helps prevent common bile duct injuries and reveals unsuspected stones. Others say false positive operative cholangiograms result in more procedures and that most asymptomatic stones discovered by cholangiography never cause symptoms. Surgeons who routinely perform operative cholangiography say it does not waste time while those who don’t do them say it does.

False negatives can occur. I have seen patients with negative operative cholangiograms readmitted within a few weeks because of symptomatic common bile duct stones.

I firmly reside on the low end of the operative cholangiography spectrum. I never perform one unless there is a specific indication as dictated by the liver function tests or a significant question involving the anatomy in the operating room.

A large, well-designed randomized controlled trial would help settle the issue, but it will probably never be done.

Who would sponsor such a study? The companies that manufacture the equipment for cholangiography certainly would have no incentive to fund it. Maybe the best we can hope for is a consensus statement from a group of expert surgeons.

Will it ever be forthcoming?

A version of this post appeared in General Surgery News in June of 2012.

A “rule” without foundation

The practice of medicine often involves “rules” that are not based on fact or evidence. Many of them are justified in a manner similar to that which we use with our children—“because.” The rationale for some rules is “that’s the way we’ve always done it.”

How about a rule prohibiting the clipping of hair in the operating room? My hospital has decided that if hair is to be clipped, it must be done before the patient arrives in the OR. One reason for this is said to be prevention of infection by loose hair.

Wait a second. It is generally agreed that the fewest wound infections result when patients are not shaved or clipped at all. If that is so (and the evidence is convincing), then why would hair cause a problem if loose? I am not aware of any data that supports the claim that clipping hair in the OR causes wound infections.

After asking about the source for this rule, I find it originates in standards promulgated by the Association of periOperative Registered Nurses (AORN). On page 367, the AORN 2011 Perioperative Standards and Recommended Practices states “Hair removal should be performed the day of the surgery, in a location outside the operating or procedure room.” The justification is said to be “Clipping the hair outside of the operating room minimizes the dispersal of loose hair and the potential for contamination of the surgical field and surgical wound.” No reference is cited.

Other sources such as the Association of Surgical Technologists’ Standards (I.3.B.) say the “shave prep should be performed in the preoperative holding area where the privacy of the patient can be maintained.” I don’t know about your OR holding area, but every holding area I’ve ever seen is far less private than the operating room itself.

The AST apparently hasn’t received the memo that “shave” is not the correct term and has not been for many years. So it’s not infection that’s the problem; it’s privacy?

In addition to not being evidence-based, the recommendation would be difficult to follow because clipping in an area outside of the OR itself will delay the case. If clipping is necessary for the purpose of applying tape after the operation, I prefer to do it myself because 1) I know it will be done without inflicting injury and 2) it will encompass only the area that I want clipped.

I performed a thorough literature search and found nothing to justify this rule regarding infection or privacy.

The problem with rules like these is that, as is the case with the 55 MPH speed limit, rules without reason are often not followed. This breeds mistrust of authority leading to failure to abide by reasonable rules too. General anarchy follows and civilization as we know it will be destroyed.

Do you know of any other "made up" rules like this?

Hyperbaric oxygen, evidence-based medicine and death

A few days ago, a tragedy occurred at a horse rehabilitation center in Florida. A horse said to be receiving hyperbaric oxygen treatment for EPM [equine protozoal myeloencephalitis] and a 28-year-old woman who worked at the farm were killed when the chamber exploded. Another woman was injured in the blast which destroyed the facility. The horse apparently became agitated and kicked off a protective horseshoe cover. A spark from the shoe ignited the explosion. Debris from the blast covered a 1200 square foot area.

Could this accident have been prevented? Some accounts pointed out that the horse should have been outfitted with aluminum shoes, which would not have caused a spark. Two workers did not reach an emergency shut-off valve in time. But what was the real cause?

For many years, people who have hyperbaric chambers have been looking for things to do with them. There is no doubt that hyperbaric oxygen is a very effective treatment for decompression sickness in scuba divers. Other than that, there is no proof in humans or animals that hyperbaric oxygen is effective in any medical illness. Two recent Cochrane reviews have found no evidence to support its use in the most commonly cited medical conditions for which it is always proposed, carbon monoxide poisoning and wounds. Both reviews call for randomized controlled trials.

A thorough search for evidence that hyperbaric oxygen works in equine neurologic diseases or wounds revealed only anecdotes. Websites devoted to the diagnosis and treatment of EPM do not mention the use of hyperbaric oxygen. There are many animal hyperbaric chambers in the United States.

I realize that all treatments need not be evidence-based. I don’t need a randomized controlled trial to prove to me that aspirin cures headaches.

But for a woman and a horse to die during a dangerous and completely speculative treatment is a truly preventable tragedy.