OR Management Digital Edition ( Winterl 2020 )

The Independent Source of News for Operating Room Managers, Supply Chain Professionals & C-Suite Volume 14 • Winter 2020

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Reproductive Risks in the OR Tips on Reducing Exposure How Hospital HVACs Fight COVID-19 Surprise Medical Bills: An Overview Achieving the ‘Holy Grail’ in Lap Chole Brought to you by the publisher of

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4 When a Cough Can Kill:

Trending Articles Online Read the most-viewed articles last month on ormanagement.net.

How Hospital HVACs Fight COVID-19

6 Achieving the ‘Holy Grail’ in Laparoscopic Cholecystectomy

1. The Role of Robotics in Hernia Repair

8 Awareness Key to Preventing OR Fires,

2. Can Silver Heal Wounds? ▼

Other Mishaps

10 The OR Carries Reproductive Risks: Here’s How to Mitigate Them

12 Surprise Medical Bills: An Overview

3. Is There a Magic Bullet for COVID-19?

14 Moneyball for Health Care: Why Hasn’t It Happened?

Heard Here First

16 Antibiotics Found Noninferior to Surgery In Randomized Appendicitis Trial

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OR Management News • Winter 2020

3

FE ATURE

When a Cough Can Kill: How Hospital HVACs Fight COVID-19

By ALISON McCOOK

A

t a hospital in Wuhan, China, a group of investigators swiped swabs over high-touch areas such as trash cans, bed handrails and computer mice, all of which tested positive for the virus that causes COVID-19. Perhaps most concerning, traces of the SARS-CoV-2 virus were present in the air.

Like influenza, COVID-19 is transmitted by respiratory droplets, which can linger in an enclosed space for more than 10 minutes. A patient who asks for a glass of water in a crowded hospital hallway can generate thousands of droplets per second. What happens to the person without a mask who steps into that air space?

Fortunately, hospitals have spent centuries improving infrastructure to prevent airborne transmission of other potentially deadly pathogens, such as the virus that causes measles, which can float in the air for up to two hours after an infected person coughs or sneezes. That infrastructure includes an intricate web of air filters and strict practices when treating patients who have (or may have) a contagious disease, with special attention paid to where procedures can generate droplet-rich aerosols.

Preventing airborne transmission of deadly diseases in hospitals “is a huge concern,” Michael J. McDavid, a technical sales representative for Professional Abatement and Remediation Technologies (PART) LLC, said. Although some hospitals are taking extra precautions because of COVID-19, he said he is “cautiously optimistic” that the same techniques that reduce the risk for measles, tuberculosis and other contagious diseases will also work for COVID-19. For companies like his, which have worked for years on air quality in health care settings, the new coronavirus is “just another pathogen we’re dealing with now.

Nothing else has changed.”

For a symbol of the fight against airborne transmission in hospitals, look no farther than Florence Nightingale, who advocated in the 1800s that facilities should take steps to improve ventilation. Over the years, hospitals have gradually developed more sophisticated building designs, always finding ways to improve air quality. “It’s a science that is continually evolving,” Mr. McDavid said.

Hospitals now have elaborate filtration systems in place, including several banks of filters in various locations. When air is taken in from the outside, it typically passes through a prefilter, which cleans the air before it hits any equipment in the hospital’s heating, ventilation and air conditioning (HVAC) system.

The air then travels through a return fan, then the heating and cooling components, another set of pre-filters, and the final filters—which, in the OR, are often high-efficiency particulate air (HEPA) filters. These are not the one- or two-inch HEPA filters the average person can buy, Mr. McDavid said. “These things are three feet deep.”

Air ducts are cleaned regularly, according to Mr. McDavid, 4

OR Management News • Winter 2020

A bad bad HVAC HVAC system system is is bad bad for for COVID-19.

COVID-119.

Earlier this year, researchers showed how one asymptomatic person likely infected nine others after all of them ate at the same restaurant, perhaps via strong airflow from the air conditioner, which spread virus-laden air between three tables. an instructor for the National Air Duct Cleaners Association’s Certified Ventilation Inspector certification training course. The NADCA’s Assessment, Cleaning and Restoration standard recommends annual inspections of air-handling units, supply and return/exhaust ducts in health care facilities.

If a contagious patient must undergo a surgical procedure, it takes place in an airborne infection isolation room, which uses negative pressure to exhaust all air to the outside, passing through HEPA filters along the way, Amber Wood, RN, the senior perioperative practice specialist with the Association of periOperative Registered Nurses, said.

Negative pressure can increase the risk for surgical site infection, so facilities often operate in a positive pressure OR and adopt additional protective measures, such as limiting staff (all of whom must wear higher level respirators, or N95 masks), using a portable HEPA filter or ultraviolet germicidal irradiation to clean the OR air and waiting for a 99% exchange of new air before using the space for other patients, Ms. Wood said.

The bottom line is a bad HVAC system is bad for COVID-19.

Earlier this year, researchers showed how one asymptomatic person likely infected nine others after all of them ate at the same restaurant, perhaps via strong airflow from the air conditioner, which spread virus-laden air between three tables (Emerg Infect Dis 2020 Jul. doi: 10.3201/eid2607.200764).

The virus is present in stool, so any traces in toilets can become aerosolized from a flush, Lidia Morawska, PhD, the director of the International Laboratory for Air Quality and Health at the continued on page 6

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PE RSP ECTIVE

Achieving the ‘Holy Grail’ in Laparoscopic Cholecystectomy

By FREDERICK L. GREENE, MD

R

arely does a manuscript get published in our mainstream and peer-reviewed surgical literature that mandates reading by all general surgeons. In my view, the recent and simultaneous publication in Annals of Surgery (2020;272:3-23) and Surgical Endoscopy (2020;34:2827-2855) by the Bile Duct Injury (BDI) Task Force achieves this benchmark.

This monumental effort, launched in 2014 with the establishment of the Safe Cholecystectomy Task Force by the Society of American Gastrointestinal and Endoscopic Surgeons, led by Michael Brunt and his colleagues, reflects a multiorganizational Delphi approach to reduce the rate of BDI as a consequence of laparoscopic cholecystectomy. After working six years and poring over multiple studies, studying innumerable databases and hosting an inperson consensus conference in 2018, this group has brought its recommendations to the mainstream surgical community.

Since management of gallbladder disease is one of the most common surgical forays for both general surgical trainees and practicing general surgeons, the findings of this task force require study, reflection and embracing by all of us. With 750,000 to

1 million cholecystectomies performed yearly in the United States, the BDI rate, estimated to be between 0.15% and 0.3%, translates to 2,300 to 3,000 BDIs per year!

Hopefully most of our readership have been fortunate to avoid any association with this demoralizing outcome. For others, the acute and long-term consequences for both patient and surgeon are devastating. The BDI task force has valiantly attempted to extrapolate administrative database information and literature reviews in making 18 recommendations for creating a safer environment for patients undergoing laparoscopic cholecystectomy. The authors are quick to point out that recommendations based solely on solid data may be ephemeral. This caution, however, does not diminish the import of well-thought-out recommendations from a cadre of experts.

One of the weaknesses in considering these strategies of data collection is the problem is always bigger than you think.

We are constantly reminded of this phenomenon during the current COVID-19 pandemic; there are always more infections than are extrapolated from existing testing data and hospital admissions. In considering BDI, many cases go unreported which leads to underreporting in global calculations. The task force authors share their own frustrations in that after 30 years of performing laparoscopic cholecystectomy,

HVAC continued from page 4

Queensland University of Technology, in Brisbane, Australia, said.

Indeed, a study of two hospitals in Wuhan, China, found elevated levels of SARS-CoV-2 RNA in aerosols taken from patients’ toilet areas (Nature 2020. doi: 10.1038/s41586-020-2271-3).

Because much about the airborne spread of the new virus remains unknown, some experts are looking to another virus for clues: SARS-CoV-1, which caused outbreaks of severe acute respiratory syndrome in the early 2000s. Researchers have documented numerous cases when the virus may have spread through the air, including in hospitals (Indoor Air 2004;15:83-95). One outbreak occurred after a patient with diarrhea visited a Hong Kong housing complex and used the toilet; soon after, more than 300 residents 6

OR Management News • Winter 2020

there is still no national registry capturing BDI data. Unfortunately, there never will be.

I was pleased that the task force embraced one of the strategies that I used beginning in 1990, and have been privileged to teach to surgical residents: intraoperative cholecystectomy (IOC). While not guaranteeing a completely safe dissection and subsequent avoidance of injury, IOC is touted by the task force as being a vital strategy that will help mitigate injury. Unfortunately, I fear that in most surgical training programs, the will and the interest to teach IOC by a preponderance of clinical surgeons is waning. It is my fervent hope that our current leaders in academic training programs will embrace the concepts of both utilization of the “critical view of safety” and IOC as promoted by the task force.

As I began, this seminal report for the mitigation of BDI should be mandatory reading for every practicing surgeon and surgical trainee. We will never fully avoid the devastation of this consequence in the performance of modern cholecystectomy. However, it is our duty to our patients and ourselves to ponder critically the outcomes over the past 30 years as we pursue the “grail” in our endeavor to achieve optimal safety.

■ —Dr. Greene is a surgeon in Charlotte, N.C.

were infected (J Epidemiol Community Health 2003;57:652-654).

Given the concerns about potentially high airborne levels in bathrooms, Dr. Morawska recommended that hospitals increase ventilation in infected patients’ bathrooms, and maintain regular cleaning of bathroom surfaces.

Fortunately, the SARS-CoV-2 virus is not measles, Mr. McDavid said; most of the respiratory droplets that contain the new virus are likely large enough that they fall to the ground or other surfaces relatively quickly. In that scenario, protecting staff and patients in hospitals is mostly a matter of adequate protective gear and housekeeping, he said, using proper chemicals to wipe down surfaces.

“Yes, the new coronavirus is something different, and we’re learning a lot about it,” Mr. McDavid said. “But, really, the same mitigation efforts are in place as for mold, asbestos and other types of mitigation that have taken place over the years.”

■

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C LIN IC A L NE WS

Awareness Key to Preventing OR Fires, Other Mishaps

By KAREN BLUM

T

he combination of oxygen, heat sources and alcohol-based skin preparations has the potential to cause fires that could harm patients and OR staff, a speaker said during the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons, held virtually this year.

Many people think of fires as a campfire with yellow flames reaching toward the sky, Edward Jones, MD, said in a session on serious mishaps in the OR. By contrast, most OR fires are fueled by an alcohol-based skin prep and appear as a blue flame, said Dr. Jones, an associate professor of surgery at the University of Colorado School of Medicine and the director of surgical endoscopy at Rocky Mountain Regional VA Medical Center, in Aurora.

Because these fires are often surrounded by blue surgical towels, they can be hard to detect and rapidly get out of control. Smoldering conditions without flames in the OR also are considered fires and can be reported per Joint Commission requirements.

“This comes into play with laparoscopy, when the fiber-optic light cord, when left in place for a short period of time, can result in burns through surgical drapes or towels,” Dr. Jones said. “This can be classified as a fire even if it doesn’t extend beyond this or cause harm to the patient.”

There are an estimated 200 to 300 reported OR fire incidents, resulting in two to three deaths, annually, according to the nonprofit ECRI Institute in Plymouth Meeting, Pa. This may sound small, but there has been an increasing number of voluntarily reported surgical device-related fires in the FDA’s Manufacturer and User Device Experience database, Dr. Jones said (J Am Coll Surg 2015;221[1]:197-205.e1). “It only takes one bad case to not only result in patient harm but also in likely harm to the hospital and health system,” he noted.

To prevent fires, Dr. Jones said, focus on three things: fuel, heat and an oxidizer. The most common oxidizers are oxygen or nitrous oxide, while heat sources include electrosurgical units, lasers or fiber-optic lights. Fuel sources can include alcohol preps as well as drapes, gowns, gauze, and even patient hair or tissue. He offered the following tips.

Be careful with supplemental oxygen. Turning up the flow on “open” oxygen systems like masks can increase the oxygen up to 50% more; draping the patient also can increase the oxygen content. Once the oxygen content increases to higher than 30%, things that are not usually flammable suddenly become so, Dr. Jones said. Use a closed oxygen system in high-risk situations.

When operating on the face, near the mouth or nose, consider using an endotracheal tube.

8

OR Management News • Winter 2020

“This isn’t 100% protective, but it’s a lot more protective than having a mask with additional oxygen right next to where you’re working,” Dr. Jones said.

Select the appropriate risk device for the procedure. When creating a tracheostomy in the airway, Dr. Jones said, don’t cut into the trachea with an energy device while the oxygen is elevated. If there is significant bleeding, skip the energy device and instead use a good surgical technique to suture leaky blood vessels.

Use caution with alcohol-based preps. Non–alcohol-based preps such as chlorhexidine or iodine are not flammable, Dr. Jones said. However, one in five cases using alcohol can be flammable (J Am Coll Surg 2017;225[1]:160-165). Even after waiting the recommended three minutes of drying time, the area is still potentially flammable, especially if the alcohol has pooled, he said. Fires can also start from alcohol that has seeped into the drapes or towels near the patient. Do not drape the patient until the prep is dry and there are no pools present.

If a fire does start, it needs to be identified immediately, Dr. Jones said. Stop the flow of airway gases if the patient is intubated and remove the endotracheal tube, especially if extra oxygen is flowing in. If there is an airway fire, pour saline in the airway and disconnect the breathing circuit. Extinguish fire on any burning material and on the patient if present, and restore breathing and care for the patient.

In addition, electrosurgical devices need to be used with caution to prevent serious OR mishaps, said Paschal Fuchshuber, MD, PhD, a clinical associate professor of surgery with UCSF East Bay, in San Francisco, and a surgeon with the Sutter East Bay group practice.

“We still call it electrocautery,” Dr. Fuchshuber said. “That’s old-fashioned and implies it’s a nonthreatening device. We’re all comfortable with it, but very few surgeons can explain the function of these devices and fewer the potential threat they represent for surgeons and patients.”

Electrosurgery still causes sparks, he said, and the electric current produces an electromagnetic field that can transfer energy from one instrument to another without the surgeon being aware.

Furthermore, if an electrical cord is wrapped around an instrument, the instrument can become electrically charged and cause burns to both the surgeon and patient. Breaks in insulation occur on 13% to 39% of laparoscopic instruments even out of the wrapper (e.g., Surg Endosc 2016;30[11]:49955001), Dr. Fuchshuber noted, and gloves are not perfect insulators to protect the hands. ■

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F E ATURE

The OR Carries Reproductive Risks: Here’s How to Mitigate Them

By ALISON McCOOK

T

here are risks that accompany a career in surgery. For example, studies have shown that female surgeons have higher rates of infertility and pregnancy complications, and not just because surgeons tend to have babies later in life (JAMA Surg 2020;155[3]:243-249).

Female surgeons face various reproductive hazards present in all medical specialties, such as injuries from sharps or infections from patients, said Aleksandra Szczęsna, a sixth-year medical student at the Medical University of Warsaw, in Poland, who has studied this topic (Ginekol Pol 2019;90[8]:470-474). There’s also plain old stress, she told OR Management News: “Surgical specialties are inseparably linked to physical and emotional burden, which increases the risk of burnout and threatens mental well-being.”

Unfortunately, the OR is home to several other potential reproductive hazards. Some, such as radiation and strenuous working conditions, are likely well known. However, others may be less familiar, like the hyperthermic intraperitoneal chemotherapy used in peritoneal carcinomatosis, and methyl methacrylate, a form of acrylic resin that’s commonly used in orthopedic surgeries.

10

OR Management News • Winter 2020

Most of the data linking these OR exposures to pregnancy outcomes are retrospective, making it hard to draw conclusions about dose-response relationships with reproductive health, said Rose H. Goldman, MD, MPH, an associate professor of environmental health at the Harvard T.H. Chan School of Public Health, and an occupational health physician at the Cambridge Health Alliance, both in Massachusetts. Barring pregnant surgeons from the OR isn’t fair, either, she added.

The best way forward, Dr. Goldman said, is to limit exposures

‘We need to not stigmatize female surgeons about it, and begin to look at the evidence and have a dialogue and some rational decision making.

And look at our operating rooms and see how we can better control some exposures.’

—Rose H. Goldman, MD, MPH

FEAT URE

to the extent possible, and at a minimum, following guidelines from regulatory agencies, so it’s safer for women—and men—to operate during their reproductive years. “We need to not stigmatize female surgeons about it, and begin to look at the evidence and have a dialogue and some rational decision making. And look at our operating rooms and see how we can better control some exposures.”

Here is a list of some reproductive risks present in the OR, and suggestions for how to mitigate them.

Waste Anesthetic Gases

Working Conditions

What’s the risk: Studies of occupational exposure to chemotherapy have shown increased risks for miscarriage, low birth weight, congenital abnormalities and infertility.

How to mitigate: Inform physicians who are pregnant or trying to conceive that current recommendations advise not participating in HIPEC administration, train them on proper use and handling of antineoplastic agents, and any physician in direct contact with HIPEC should use triple gloves and change them every 30 minutes.

What’s the risk: In some studies, working more than 40 hours per week has been linked to increased risk for preterm delivery and miscarriage; night shifts are associated with preterm delivery and miscarriage.

How to mitigate: Educate physicians about the potential risks and provide alternative conditions that aren’t unfairly restrictive.

Radiation What’s the risk: Studies report a higher risk for fetal death (estimated threshold dose, 50-100 mGy), congenital abnormalities and growth restriction (estimated threshold dose, 200-250 mGy), cognitive effects with microcephaly (estimated threshold dose, 60-310 mGy), and childhood cancer (likely minimal risk at <10-20 mGy). These exposures are much higher than are found in the OR, Dr. Goldman said.

How to mitigate: Keep exposure as low as possible, mandate use of protective gear and maintain distance from the radiation source. Women who are pregnant should wear fetal dosimeters under their protective gowns near their abdomen, and have access to counseling by a qualified expert.

Surgical Smoke What’s the risk: Although much of the research on surgical smoke focuses on its components and does not focus on physicians, experts are getting a better picture of its potential health risks to providers. Studies of reproductive risk have associated particulate matter with low birth weight and preterm labor; toluene with congenital defects, cognitive problems and infertility; benzene with childhood leukemia; and 1,2-dichloroethane with miscarriage and infertility.

How to mitigate: Use a ventilation system, employ smoke activators with adequate capture velocity (31-46 m per minute), cut back on surgical smoke as much as possible, and use a high-filtration mask for standard procedures and an N95 mask in the presence of aerosols.

What’s the risk: There is a potential for miscarriage, congenital abnormalities and infertility.

How to mitigate: Follow recommendations of the U.S. Occupational Safety and Health Administration, use ventilation and anesthetic gas‒scavenging systems, maintain equipment, avoid high flow rates and other high-waste techniques, and monitor breathing zone atmospheric gas levels.

Hyperthermic Intraperitoneal Chemotherapy

Methyl Methacrylate What’s the risk: High exposures in animals are linked to skeletal abnormalities and growth restriction.

How to mitigate: Install laminar flow ventilation, use surgical hooded helmets, and use vacuum cement mixing systems and local suction during preparation.

Female surgeons can take on less physically demanding activities during pregnancy without interrupting their career goals, said Joanna Kacperczyk-Bartnik, MD, an obstetrics and gynecology resident at the Medical University of Warsaw, in Poland. (One example, Ms. Szczęsna said, would be avoiding the night shift, either in person or on call.) “More emphasis on the scientific work, attendance at theoretical courses, training in nonsurgical wards, gaining skills essential in the diagnostic process and follow-up care are the examples of much safer options within the residency curriculum than the OR,” Dr. Kacperczyk-Bartnik said.

Although the data focus on female reproductive issues, men need to be aware of the risks and advocate for change, Dr. Goldman said. It’s very possible that some of the risks to female reproduction also affect men, so limiting exposures is “going to be good for everybody,” she said, “because there are the risks we know, and the risks we don’t know. But when we control exposures, we basically control unknown risks, as well.”

■ Source for all: (JAMA Surg 2020;155[3]:243-249) OR Management News • Winter 2020

11

BUSIN E SS M A NAG E M E N T

Surprise Medical Bills: An Overview view Unexpected Out-of-Network Charges

By VICTORIA STERN

M

ore than $28,000 to remove an appendix, almost $94,000 for spinal surgery, over $500,000 for lifesaving dialysis treatment—these figures represent just a few of the unexpected medical bills patients have received, according to Kaiser Health News’ “Bill of the Month” column.

Concerns about surprise bills continue to mount as more people share their stories and as researchers dig into the extent of the problem.

“Surprise medical bills can be financially devastating,” said Karen Joynt Maddox, MD, an assistant professor at Washington University School of Medicine in St. Louis. “As a patient, you trust that if you have insurance you will be covered, but that is not how these scenarios are playing out.”

A surprise or balance bill can occur when a patient with health insurance unintentionally receives care from an out-of-network provider. When an insurance company and hospital or clinician don’t have a contract in place that sets payment rates, the clinician is considered “out-of-network” and the insurance company isn’t obligated to pay, Dr. Joynt Maddox explained. That often leaves patients responsible for the bill.

But how common are these types of charges?

An analysis published last year found that among almost 20 million privately insured patients, out-of-network bills accompanied more than 40% of emergency department visits and inpatient admissions in 2016 (JAMA Intern Med 2019;179[11]:1543-1550).

A 2019 survey from the Kaiser Family Foundation estimated that 18% of emergency visits and 16% of inpatient admissions at in-network hospitals led to an out-of-network bill. Of inpatient admissions, surgical visits led to a higher rate of out-of-network charges, at 21%.

In an emergency or time-sensitive scenario, a patient will likely not have the ability to pick an in-network doctor or hospital.

But what happens when patients do have time to shop for an innetwork provider and facility?

Karan R. Chhabra, MD, who ‘In the elective studies the affordability of surgical care at the University of Michigan, surgery setting, in Ann Arbor, wanted to find out. patients are getting Dr. Chhabra and his colleagues analyzed bills from almost 350,000 charged thousands patients who had gone to in-network of additional dollars surgeons and facilities for elective operations (JAMA 2020;323[6]:538from a clinician 547). What he found surprised him: they didn’t have an 20% of patients received an out-ofopportunity to pick.’ network bill. The average bill came to $2,011.

—Karen Joynt Maddox, In other words, “out-of-network MD, MPH bills occurred just as often for elective

12

OR Management News • Winter 2020

Table 1. Rates of Out-of-Network Bills Across 7 Procedures Procedure

Overall

Average bill, $

Frequency, %

2,011

20

CABG

3,326

33

Colectomy

3,449

24

Lap Chole

1,255

24

Total Knee Replacement

2,786

25

Hysterectomy

2,174

26

Table 2. Drivers of Out-of-Network Billing in Elective Surgery, by Provider Specialty Provider

Average bill, $

Frequency, %

Surgical Assistant

3,633

37

Anethesiologist

1,219

37

Radiologist

321

7

Pathologist

284

22

a

Figures don’t add up to 100%; some patients received out-of-network bills from multiple providers.

CABG, coronary artery bypass graft surgery Source: Dr. Chhabra’s analysis. https://ihpi.umich.edu/news/ihpi-briefs/surprisebilling.

surgeries as they do for emergency visits,” Dr. Chhabra said.

Dr. Chhabra’s team could only estimate the potential surprise bill stemming from these out-of-network charges because the data did not specify what portion of the out-of-network bill insurers ultimately paid. Some insurers, for instance, may cover part of an out-of-network bill whereas others may leave patients on the hook for the full amount.

The most worrying finding, Dr. Chhabra said, was that these patients had chosen in-network providers and facilities. Dr. Chhabra’s team found that the largest proportions of cases of potential surprise medical bills cases involved out-of-network surgical assistants and anesthesiologists, but other providers, such as radiologists and pathologists, also had a part.

“So, in the elective surgery setting, patients are getting charged thousands of additional dollars from a clinician they didn’t have an opportunity to pick,” said Dr. Joynt Maddox, who is also the co-director of her university’s Center for Health Economics and Policy. “Although the issue of surprise medical bills is not new, continued on page 21

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Moneyball for Health Care: Why Hasn’t It Happened?

By BRUCE RAMSHAW, MD

“M

oneyball,” a book by Michael Lewis, and later made into a movie starring Brad Pitt, describes the success of applying the principles of data science to develop a winning strategy in baseball. It’s a transferable skill, so why hasn’t Moneyball happened in health care? You would think if data science can be used to win more games in baseball, it could be used to lower costs and improve outcomes. Data science is about measurement and improvement. In baseball, the measurement to be improved is runs scored with the lowest possible budget—producing the most wins per dollar spent.

Similarly, if we want a sustainable health care system, we should measure and improve the value of care we provide, resulting in lower costs and better outcomes over time. If you can measure something, it can be improved. But if something is not being measured, it can’t be improved—and we’re not measuring the value of care in health care, in any organization, in any health care system in the world.

For data science to work, there are basic rules. First, data requires “context,” or a definable process. Attempting to apply data science without context doesn’t work. In sports, context is provided by the specific set of rules for a particular game, like baseball: nine players, three outs, three strikes, nine innings, etc.

The insight from the application of data science tools applied to baseball will not work the same if applied to a different sport such as American football, with 11 players, four quarters, four downs, etc.

In health care, context means defining each whole patient care process. The specific patient and treatment factors and outcome measures collected will be different for different types of Probably the patient care processes. For most harmful habit example, outcome measures used to define the value of of all, we’ve allowed care for a breast cancer pro- health care leaders to cess will not be the same as continue to push the those used for a ventral hergrowth and volume nia process.

Another principle of data model despite the science is it should be applied to measure and improve out- harm done not only to comes that matter most. In patients, but to doctors baseball, what matters most and other caregivers to improve the value of the team performance is com- as well. bining salaries (financial measures) with factors that result in the most runs and wins (e.g., on-base 14

OR Management News • Winter 2020

percentage). Applying data science to measure and increase the number of pitches thrown will likely not help win more games.

We’re not typically measuring outcomes that matter in health care. We tend to measure things that are easy to measure, such as if antibiotics are given before surgery, rather than the factors that improve the value of care the most. We document these easy-tomeasure factors, often because of perverse financial incentives or penalties, without measuring to see what effect they have on outcomes. To truly measure value, we should be combining financial measures with outcome measures that matter in the context of each definable whole patient care process. Until we do, we can’t lower costs and improve patient outcomes at the same time.

From reductionist tools, like prospective randomized controlled trials, we’ve learned to apply treatments that seem best for the average patient to all patients, regardless of differences in each local environment and the biologic variability of patient subpopulations. We’ve learned that training to be a doctor should allow us to use our training and experience, without appropriate data, to make treatment recommendations. Probably the most harmful habit of all, we’ve allowed health care leaders to continue to push the growth and volume model despite the harm done not only to patients, but to doctors and other caregivers as well.

The financial constraints and inequities in health care are worsening and are contributing to more and more harm for patients, employers and in some cases, even for doctors themselves. Tragically, there are reports in the United States of young people dying because they can’t afford insulin. Doctors are dying by suicide at a rate greater than in the general population.

A main challenge to make necessary changes in health care is to let go of the pride and the belief that we (doctors, hospitals, insurers, even patients sometimes) know what is best for any given situation. Letting go of beliefs and the way we’ve always done things is hard and uncomfortable. But discomfort is a normal and necessary part of learning, and transformation can’t occur without changing our mindsets and the structure for how we care for patients and manage data.

There is a major difference between applying data science to baseball and to health care. Ultimately, baseball is a competitive sport—it’s about winning, beating another team. In health care, we should not be competing. We should be focused on a goal that aligns all of us: improving the value of care for all patients with any disease or health problem. When we align around the goal of value and work collaboratively to improve value for patients, we can apply one of the most important tools of data science: the ensemble model for learning. If every clinical team in each local environment were to implement a value-based continuous learning model and then network continued on page 22

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Antibiotics Found Noninferior to Surgery In Randomized Appendicitis Trial

By CHRISTINA FRANGOU

I

n a large randomized trial comparing surgery with antibiotics in adults with appendicitis in the United States, antibiotics were noninferior based on 30-day health status.

Seven of 10 adults with appendicitis safely avoided appendectomy for 90 days by receiving a course of antibiotics, according to findings from the ongoing CODA (Comparison of the Outcomes of antibiotic Drugs and Appendectomy) trial.

That number fell to six out of 10 for patients with appendicoliths. Of patients randomized to antibiotics first, 41% underwent appendectomy within three months, compared with 25% of those without an appendicolith. Furthermore, patients with appendicoliths were more likely to have a perforation if they underwent surgery.

“The way I interpret these results … antibiotics are reasonable for some patients, probably not all patients. It really helps to figure out what the patient wants when deciding on the different treatment options,” said co-principal investigator David Flum, MD, a professor and the associate chair of surgery at the University of Washington School of Medicine, in Seattle. “(This) gives information to people so that, based on their characteristics, their preferences and their circumstances, including maybe COVID-19, they can figure out what’s right for them,” Dr. Flum added.

He presented the results at the 2020 American College of Surgeons’ Clinical Congress, which was held virtually. The study was published in The New England Journal of Medicine (2020 Oct 5. doi: 10.1056/NEJMoa2014320).

The results of the CODA trial have been highly anticipated since its launch in 2016. The trial is unusually large, with 1,552 adults who underwent randomization and a pragmatic design intended to accommodate the broad range of patients seen in realworld practice environments in the United States. Participants were ethnically diverse, with one-third whose primary language is Spanish. Unlike most other trials of antibiotics to treat appendicitis, patients with appendicoliths and severe disease were included.

The COVID-19 pandemic heightened the urgency for results from the trial, which completed enrollment just as the pandemic was declared. In some places in the United States, health care resources became strained, leading the American College of Surgeons to suggest that hospitals and surgical centers consider nonoperative management when applicable. The ACS noted the limited evidence suggesting that patients with uncomplicated appendicitis can be managed with IV antibiotics. Some patients also wanted an antibiotics-first strategy to avoid time in the hospital, Dr. Flum said.

Consequently, the CODA investigators decided to review outcomes from the first 90 days after randomization, a full year earlier than planned.

16

OR Management News • Winter 2020

Among patients who did not have an appendicolith, complications were similar in the two arms:

2%

antibiotic group

2.9%

On average, patients who received antibiotics as opposed to undergoing appendectomy missed But were likelier to need another hospitalization, including appendectomy:

surgery group fewer days of work

3.4 24% vs. 5%

47%

of patients in the antibiotic group received their initial care in the emergency department and avoided hospitalization for initial treatment.

The researchers randomly assigned 776 patients each to undergo appendectomy or receive a 10-day course of antibiotics administered intravenously for the first 24 hours and then as pills on the remaining days. An appendicolith was found on imaging in 27% of the participants.

The primary outcome was patients’ health status 30 days after treatment using a measure of general health, the European Quality of Life-5 Dimensions (EQ-5D). Both treatment groups had continued on page 22

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C LIN IC A L NE WS

Pressure Injuries: What to Do When Surgery Fails

By CHASE DOYLE

A

dvanced-stage pressure injuries, or pressure ulcers, are a difficult and increasingly common problem whose challenges persist long after the completion of surgery. Meticulous postoperative care and timely management of complications are critical to a successful outcome.

During the Symposium on Advanced Wound Care (SAWC) 2020 virtual meeting, John C. Lantis II, MD, the vice chairman and a professor of surgery at Mount Sinai West and St. Luke’s Hospitals/ Icahn School of Medicine, in New York City, discussed risk factors associated with recurrence after surgery and presented several nonsurgical options for managing pressure injuries.

As Dr. Lantis explained, the standard nonsurgical treatment for a clean, fullthickness pressure ulcer is wound cleansing followed by topical dressing, pressure redistribution, elimination of drainage, and supportive care. With this approach, six-month healing rates are 40% to 45% for stage III ulcers and 31% to 34% for stage IV ulcers (J Am Geriatr Soc 2004;52[3]:359-367).

For patients who undergo flap reconstruction surgery, however, a large retrospective study showed a complication rate of 58.7% (Plast Reconstr Surg Glob Open 2017;5[1]:e1187).

“In patients with low body mass index, ischial pressure ulcers, diabetes and active

smoking habits, surgical interventions may have more limited success,” said Dr. Lantis, who noted various perioperative protocols. “It’s important to maximize nutrition, control blood pressure, and utilize off-loading techniques.

“For ischial tuberosity pressure injuries, patients should wait at least six weeks before sittings and start with just 10 minutes of sitting at a time,” he added.

According to Dr. Lantis, recurrence and nonoperative management of pressure injuries are often identical, and patients who recur after flap reconstruction surgery rarely return to the OR. Dr. Lantis summarized the evidence for several nonsurgical treatment approaches: Debridement: A retrospective chart review of sacrum, sacrococcyx, coccyx, ischium and trochanter region pressure injuries showed that bedside surgical debridement using a sharp excisional technique was performed on 190 of 319 (59.5%) of wounds (Wounds 2017;29[7]:215-221). Of those 190 wound sites, 138 (73%) had a reduction in square surface area, and there were a total of 43 (23%) wounds that had a square surface area of 0 (reepithelialized), which has a healing rate of 23%.

Negative pressure wound therapy: Overall, there is low-quality and inconclusive evidence regarding the clinical effectiveness of negative pressure wound therapy

as a treatment for pressure ulcers, who cautioned against routinely offering this treatment unless it is necessary to reduce the number of dressing changes (e.g., in a wound with a large amount of exudate).

Cellular and tissue-based therapy: Results of a small randomized study suggest that weekly treatment of chronic pressure ulcers with small intestinal submucosa wound matrix increases the incidence of 90% reduction in wound size versus standard of care alone (J Tissue Viability 2019;28[1)]21-26).

Transdermal topical oxygen: A single-blind, multicenter, randomized controlled trial found greater wound healing in the experimental group after 12 days of wound oxygen therapy, which suggests this approach may promote wound healing in patients with pressure ulcers (Iran Red Crescent Med J 2015;17[11]:e20211).

Stem cell therapy: Preliminary data indicate that cell therapy using autologous bone marrow mononuclear cells could be a treatment option for stage IV pressure ulcers in patients with spinal cord injury and could help avoid major surgical intervention (J Spinal Cord Med 2011;34[3]:301-307).

In 19 patients (86.36%), the pressure ulcers treated with this approach had fully healed after a mean time of 21 days.

Anabolic steroids: A trial ended early after interim results demonstrated an unlikely benefit from treatment with oxandrolone (Cochrane Database Syst Rev 2017;6[6]:CD011375). There is no highquality evidence to support the use of anabolic steroids in treating pressure ulcers.

“Based on a review of the literature, postsurgical dehiscence can be well managed with ongoing sharp debridement, and topical oxygen therapy may help facilitate these closures,” Dr. Lantis concluded. ■ Dr. Lantis has been a consultant to, or a principal investigator for, 3M, Coloplast, Integra, Kerecis, MediWound, Pluristem, Smith & Nephew and TissueTech.

18

OR Management News • Winter 2020

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CLIN IC A L NE WS

Protect Yourself From Counterfeit PPE

By BOB KRONEMYER and BRIAN DUNLEAVY

As the need for personal protective equipment (PPE) for nurses has remained at the forefront during the COVID-19 pandemic, there has been a heavy reliance on imported and online sources. However, many of these masks are counterfeit respirators, such as the KN95 masks from China, as opposed to a National Institute for Occupational Safety and Health (NIOSH)-approved N95 respirator.

“This is a huge concern, and it’s something that we’ve been stressing because these counterfeits are putting people’s lives in danger,” Tener Veenema, PhD, MPH, RN, a professor of nursing at the Johns Hopkins University School of Nursing, in Baltimore, said in a virtual news brief held by the American Nurses Association (ANA).

“Many hospitals are paying millions of dollars, but then find out that their purchase isn’t able to provide health care workers on the front lines with safety. The solution to this issue is the ample production of approved N95 masks where there is no break in the seal. Our attention needs to shift heavily to that.”

How to Distinguish Between a Quality and Counterfeit Mask The NIOSH website allows the entry of N95 mask information and whether it has been deemed approved by NIOSH. Once a mask has been identified as counterfeit, a photo of the mask is posted on the website.

To determine whether a mask is still safe for use after an extended period of usage, check whether the manufacturing label states that the mask can be reused, and if so, for how long.

Tips for Safety Verification 1. Check whether there is a NIOSH approval number, a NIOSH logo, and that it’s spelled correctly.

2. What filter classifications are listed on the mask?

3. Is there a lot number on the mask that can be verified, along with the model number?

4. Is there a mask brand name that is easily understood and a registered trademark?

Fit and Efficacy Deteriorate With Reuse of N95 Masks Nearly half of all N95 masks worn by anesthesiologists during the COVID-19 pandemic fail fit tests after four days of reuse, according to an analysis published by the British Journal of Anaesthesia (2020;125[3]:e322-e324).

The results, based on assessments performed on 74 anesthesia providers at Washington University School of Medicine in St. Louis (WUSTL), suggest that many of the masks being worn by health care professionals during the height of the SARS-CoV-2 outbreak in the United States did not provide an adequate “seal to the face … to ensure small aerosolised droplets are filtered,” the researchers said.

“In most cases, simply wearing a disposable N95 respirator eventually damages it to the point it can no longer form a 20

OR Management News • Winter 2020

seal to the face,” said study co-author Ryan Guffey, MD, an assistant professor of anesthesiology at Barnes-Jewish Hospital/ WUSTL. In general, “risk of seal or fit failure increases with the amount of time the respirator has been worn,” he added.

Shortages of N95 masks and other PPE at hospitals across the country have been well documented. Lack of available masks has forced many hospitals to encourage staff to reuse them—following cleaning and decontamination.

For their research, Dr. Guffey and his colleagues performed repeat N95 fit testing on 74 anesthesia providers, 46 of whom were women and 28 of whom were men. Overall, they found that female anesthesiologists were more likely to fail fit testing (63%) than their male colleagues (29%).

Failure rates were 46% after four days of wear, 50% after 10 days, and 55% after 15 days.

N95 respirators that failed fit testing were worn a median of eight days and used a median of 18 times, the researchers reported. However, 73% of users

C LINICA L NEWS

New Survey Shows PPE Shortage Remains a Challenge Findings from a recent ANA survey echoed oed what has been a dire predicament from the onset of the COVID-19 pandemic: that 42% of respondents still experience widespread or intermittent shortages of PPE. The online survey, which was complet-ed by over 21,000 American nurses, found that half of nurses reuse single-use PPE, like N95 masks, for at least five days, and that 68% said reuse is required by their facility’s policy.

The survey also revealed that 38% of nurses decontaminate their N95 masks, s, despite the fact that the ANA does not consider the use of decontamination methods for masks as a standard practice. Overall, 53% of nurses said id reusing i and decontaminating masks makes them feel unsafe.

“Nurses feel stressed that they have to reuse masks, even with proper decontamination, because the materials will all eventually deteriorate,” Dr. Veenema said.

“Masks can be contaminated with pathogens other than COVID-19, which further complicates their cleaning. Some nurses, even at large institutions, have been reusing masks since March.”

with N95 masks that failed testing believed their respirators fit well, while testers believed that 89% of N95 masks with failed fit tests “were of good or like new quality,” the researchers said.

“Despite being trained on user seal testing, participants could not reliably detect poorly fitted respirators without formal fit testing,” Dr. Guffey said.

Based on their findings, he and his colleagues recommend that, if local supplies allow, use of disposable N95 respirators be based on CDC guidelines, which limit reuse to five times (https:// bit.ly/36KV24h).

“This corresponds to one to two shifts for health care workers with exposure to patients with COVID-19 in our study population,” Dr. Guffey said.

Use of reusable elastomeric respirators can help decrease disposable N95 demand, he added, as can universal COVID–19 testing before hospital admission. In addition, universal masking

of patients also can decrease risk for virus transmission and, thus, N95 demand, according to Dr. Guffey.

“As testing becomes more accessible, we should advocate for single use with N95 masks in patients that are confirmed positive,” said Bryant Tran, MD, FASA, an assistant professor of anesthesiology and the director of the Regional Anesthesia and Acute Pain Medicine Fellowship at Virginia Commonwealth University Medical Center, in Richmond, who was not involved in the WUSTL study but has published research on similar topics (Geriatr Orthop Surg Rehabil 2020;11:2151459320930554).

“This is especially important for [clinicians] who are performing high-risk aerosolizing procedures such as intubations,” he continued. “With a PPE shortage, reuse of N95 masks may be most appropriate in patients who are undergoing an aerosolizing procedure and have tested negative for the coronavirus.”

■

Surprise Billing continued from page 12

our recognition of how common it is has grown recently.”

Regarding working toward a solution, for Dr. Chhabra, “my biggest takeaway for surgeons is to try, when possible, to work with a surgical assistant who is in the patient’s network.”

No Simple Fix Patients, doctors, policymakers, even insurers and hospitals agree that consumers need to be protected from these surprise out-of-network bills.

The challenge, however, has been finding a solution at a national level that all parties can agree on. Surprise billing legislation currently being considered in Congress would ensure patients being treated at in-network hospitals pay in-network rates for bills under $750, even if an outof-network provider was involved in their care. For bills of $750 and over, clinicians or insurers could opt to go through an arbitration process where an independent party would decide how much the insurer should pay the provider.

“We’re facing a classic scenario in which we need legislation, but the legislation proposed so far has gotten pushback from all sides,” Dr. Joynt Maddox said. “Physician and hospital lobbies don’t think the fixes give them adequate compensation, while insurance companies and patients may not think the proposals go far enough.”

With no national-level legislation, some states have adopted their own surprise billing laws with varying degrees of protections for consumers.

However, Dr. Joynt Maddox does not see state laws as a solution to surprise medical bills. “Surprise medical bills are a symptom of a completely broken health care market,” she said. “We can patch the system and limit the bleeding, but it’s not solving the problem of what got us here—that the market isn’t working to limit costs of care due to hospital and insurer consolidation and a lack of transparency. That said, I hope the patches we come up with can save patients from medical bills that threaten their financial ■ security.”

OR Management News • Winter 2020

21

Appendicitis Trial continued from page 16

similarly improved health on the EQ-5D, but each treatment showed advantages and disadvantages.

Complications were more common in patients receiving antibiotics, but the difference was attributable to the presence of an appendicolith. There were 9.3 serious adverse events per 100 participants with an appendicolith who received antibiotics, compared with 3.6 per 100 in the surgery group. Among patients who did not have an appendicolith, complications were similar in the two arms: 2.0 in the antibiotic group and 2.9 in the surgery group per 100 participants.

Patients who received antibiotics, on average, missed 3.4 fewer days of work than those undergoing appendectomy (5.3 vs. 8.7 days), but were likelier to need another hospitalization, including for an appendectomy (24% vs. 5%). In the antibiotic group, 47% of patients received their initial care in the emergency department and avoided hospitalization for initial treatment.

The study addressed a question that has long concerned surgeons: Are patients treated with antibiotics at greater risk for perforation and more surgical complications? The answer appears to be no unless they have an appendicolith, but it’s not perfectly clear.

Patients in the antibiotic arm had lower rates of perforation overall (9% versus 15%), but it was an expected finding given that patients who were not operated on could not be assessed for perforation.

When the analysis was limited to participants from either arm who underwent an appendectomy, perforation was nearly twice as frequent in the antibiotic group: 31% compared with 16%. However, again, this difference was attributable to the presence of an appendicolith. Overall, the rate of more extensive procedures like small-bowel or colon resection, reoperation or ileostomy was low and similar in the two groups.

“Once you control for the presence of an appendicolith, there was really no difference in the two groups in terms of the rates of complication. There’s really no reason to think that antibiotics allow a patient to progress to perforation,” said Katherine Fischkoff, MD, a surgeon at NewYork-Presbyterian/Columbia University Irving Medical Center, in New York City, one of the study authors who spoke at the ACS meeting.

Appendiceal neoplasms were identified in nine participants, who had a mean age of 47 years (range, 21-74 years). Of these, seven were in the appendectomy group and two in the antibiotic group who underwent appendectomy. Eight of the neoplasms were carcinomas and one was a mucocele.

Moneyball continued from page 14

the learnings from each clinical team, we could improve value forever.

Data science is real, but very different from the reductionist science paradigm we’ve been taught and are functioning 22

OR Management News • Winter 2020

At the beginning of the trial, researchers were concerned that increasing antibiotic management in the United States could lead to rare cancers of the appendix being missed, said Giana H. Davidson, MD, MPH, a study investigator and an associate professor of surgery at UW School of Medicine. They hope this trial will identify radiographic and patient characteristics that place someone in a higher risk category for these cancers.

That information will help clinicians and patients make decisions about treatment options and what to monitor over time, she said. “Decision makers have to weigh the characteristics, the preferences and circumstances. We found one size doesn’t fit all,” Dr. Davidson said.

She noted that this report reflects early outcomes and the rate of appendectomy is likely to increase with longer follow-up.

The coronavirus infection itself may affect outcomes after surgery, although this was not studied in the CODA trial. In July, the international COVIDSURG Collaborative published a cohort study of 1,128 patients from 235 hospitals in 24 countries who had surgery between Jan. 1 and March 31, 2020, which showed postoperative pulmonary complications occurred in half of patients with preoperative SARS-CoV-2 infection.

This comorbidity was associated with higher mortality (Lancet 2020;396[10243]:27-38).

In an editorial accompanying the COVID-19 trial results, Danny Jacobs, MD, a surgeon and the president of Oregon Health & Science University, in Portland, said he believes that all options must be discussed with a patient, but most providers would still recommend surgical treatment for uncomplicated appendicitis if laparoscopic appendectomy is available. That said, the pandemic will affect people’s decision making, he wrote.

“Circumstances do matter, and advantages of antibiotic treatment relative to surgery may be greater during the COVID-19 pandemic or other public health emergency in which operating room capacity and other resources are severely constrained,” Dr. Jacobs wrote.

It’s important to ensure that people, especially vulnerable populations, are not offered antibiotic therapy preferentially or without adequate education, he added.

The study has several limitations, including short follow-up.

There was no standard technique for performing an operation or giving antibiotics, nor a standard indication for appendectomy for patients randomized to the antibiotic arm. In addition, women were underrepresented, accounting for one-third of participants. Men and women have a relatively equal chance ■ of appendicitis.

under in health care today. Until we feel that the pain of continuing to suffer in this reductionist status quo is worse than the discomfort of learning and applying a new data science paradigm, like Moneyball did for baseball, we will continue to suffer the consequences. I believe the inequities and harm resulting from our current system

structure are enough to commit to making this change now.

■ —Dr. Ramshaw is a general surgeon and data scientist in Knoxville, Tenn., and a member of the ORM editorial advisory board. You can read more from him on his blog: www.bruceramshaw.com/blog.

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