Do you know this man?

I was flipping through the Washington Post today and noticed this advertisement on the back page of the first section, probably the most expensive location in the newspaper.  It is an ad for Eliquis, a blood thinning agent for people with atrial fibrillation that is presented as an alternative to warfarin.  I make no judgment about the relative efficacy of the drug compared to others, but I was drawn to the question of why Bristol-Myers Squibb chose this particular male model to represent its product.

What is it about this image that someone has concluded will draw people to ask their doctor to prescribe this medication? I have to guess that BMS's ad agency conducted focus group sessions, testing out this photo against others.  I wonder what other faces were offered?

Can we parse this fellow's visage?  It is a male with gray hair showing.  Is this meant to send the message that he understands the problems of older men?  Perhaps people would view him as ruggedly handsome, so is the company playing to the fear of men that their virility would be at risk with AF?  And that this problem would be solved by Eliquis?  (I thought that product was sildenafil citrate, produced by a competing firm, Pfizer.)  How do any of these factors relate to the other target audience, women?

So I decided to call the 855-ELIQUIS number and ask.  A friendly and helpful person answered.  I wondered who the person in the ad was, saying that I assumed it was someone notable who was endorsing the product.  The person on the phone said she would research that question.  She returned shortly thereafter and said that she was sorry, but they "didn't have any information on that question at this time."

I went to our favorite source, Google.  On January 24, 2013, Medical Marketing and Media noted the FDA's late-2012 approval of the drug and reported:

The company sees advertising and promotion spending “increasing in the high single-digit range” for 2013....

“Higher spending is strategically prudent to assure a successful Eliquis launch,” said CreditSuisse's Catherine Arnold in an analyst note.

But no hint of a rationale for this photo.

But not to worry.  The FDA is on the case.  MMM reports:

According to OPDP (Office of Prescription Drug Promotion), “Our objective as an agency is to increase the quality of DTC (Direct to Consumer) ads so they do not contain any misleading information and instead provide patients with good information about prescription drugs and medical conditions.”

So whatever the rationale for this photo, we can be confident that it contributes appropriately to consumer understanding of this drug and does not attempt to use any subliminal messaging to encourage people to use it.

A warm farewell and welcome to full time in education

Check out this lovely column about Robin Dibner, who is leaving medical practice to devote full-time to residency education.  One quote:

When you are in an ambulatory practice as an attending, whether solo, group, specialty, or faculty practice – you and your patients choose each other.  Over time the ones who are not a good fit drift away.  The ones who remain loyal are wonderful!  And you learn to work with each one in a collaborative relationship to promote their health, adherence to treatments, and prevention.  They learn to trust you, and you them.

Goal Play! at NE Mobile Book Fair

Thanks to New England Mobile Book Fair at 82 Needham Street in Newton for inviting me to present a reading and signing of Goal Play!  It will be held Wednesday, August 14 at 7pm.  Here are the details.  Please come by!

Infrastructure heroes

I used to run the regional water and sewer system for the Boston metropolitan area, and I found that the people on the front line who operate these systems are among the unsung heroes in our communities.  (In that regard they are similar to many of the front-line staff people in hospitals.)  Here's a wonderful story from the Washington Post about a group of folks at the Washington Suburban Sanitary Commission who, by dint of dedication, persistence, and hard work, helped avoid a difficult situation in their community.  The lede:

Brad Destelhorst stood in the dimly lit, musty vault — a small concrete room 20 feet underground near the Capital Beltway — and tried not to think about his soaked feet, or the muddy water he stood in, or the fact that more than 100,000 people in southern Prince George’s County needed him to fix the unfixable.

For almost 12 hours Tuesday, Destelhorst and fellow mechanics for the Washington Suburban Sanitary Commission chiseled years of thick rust off gears that corrosion had frozen in place and then fashioned new gears out of the gunked-up pieces of metal. 

Other crews had spent three days trying to fix the valve.... But with new parts for the 48-year-old valve unavailable, the other crews had said they found it impossible to repair. 

Destelhorst, an admittedly stubborn former auto mechanic from Crownsville, wouldn’t have it. He said Thursday that he was prepared to break every tool he had to get the gears turning and the valve closed.

“No one should have to go without water,” he said.

We often take underground infrastructure for granted. Let's not forget the need to maintain it properly or the dedicated folks who keep it operating.

Health care can be a religious experience

As I noted in the previous post, patients from around the world write to tell me of their hospital experiences.  It seems that each one offers a series of lessons.  But truly, I am not sure what the lesson is from this story except that we should try to maintain a good sense of humor!

The experience was not so fun at the time, but I look back now and laugh. Over the past three years I have battled repeat episodes of sudden cardiac arrest. In September 2010, I spent 10 days in the heart hospital here in Columbus. One morning at 4:30, the nurse woke me up abruptly to draw my blood in preparation for early rounds. Of course, I was less than thrilled to be woken up after a restless night, attached to wires, machines, in pain. She missed the vein the first three tries, removing the same needle twice from my arm, then diving back in. I watched in horror as she used the same needle. On the fourth try she dug deep and caused considerable pain. I jerked my arm without thinking and said, "Jesus Christ, that hurt!". The nurse scowled. I expected her to tell me she felt sorry, or that she didn't mean to hurt me. Rather, I got, "Oh no, you don't take the Lord's name in vain!" I'm Jewish. At the time, I thought I had landed in a Woody Allen film and was being held captive for having a Rabbi. 

I felt like I had to defend why I was there

Patients from around the world write to tell me of their hospital experiences.  It seems that each one offers a series of lessons.  The most interesting stories are not those associated with reportable adverse events.  They are the ones that demonstrate inefficient work processes and insensitivity to patients' needs.  My hope in posting them here is to prompt administrators and clinicians to think about doing better. It doesn't matter if the particular event occurred in your hospital.  Chances are that something like it has.  We need to stay focused on continuous improvement based on call-outs from the front line staff and on reports we receive from patients.

Today's story involved a woman in the mid-thirties.  Three years ago, her primary care doctor noticed a lump in her breast and sent her in for imaging studies.  While the doctor did not think the lump was cancerous, she ordered studies just to be sure.  The result was satisfactory.

The woman returned for another periodic physical exam a few weeks ago, and her doctor again noticed the lump in the same place.  While reasonably confident it was not problematic, she again ordered a mammogram and ultrasound out of an abundance of caution.

The patient arrived at the hospital's breast imaging center at 1:50pm for a 2:00 appointment, did the paperwork, and was directed to back room holding area to await the mammogram.  At 2:30, the tech showed up and spent less than 10 minutes taking the picture.  Then it was back to the waiting room until 3:20, when the ultrasound tech came in and spent less than ten minutes doing her job.  The radiologist arrived and spent five to ten minutes reporting on the results, which again confirmed that there was no problem.  Elapsed time, almost two hours for at most 30 minutes of useful time spent.

So, conclusion number one.  Here is a center that needs a lesson in Lean.  The number and duration of wasteful steps is obvious. Compare this to other clinics that have applied the Lean philosophy and techniques to improve customer (and staff) experience.

But we have to return to the doctor to reflect a different sort of problem.  As the radiologist was reporting the current test results to the patient, she noted that the 2009 studies had shown no problem and asked the patient who had noticed the lump, implying in the ears of the patient that she (the doctor) was wondering why the test was being repeated. 

The patient reported to me that, while the radiologist had not been dismissive, she did make the patient feel "like I had to defend why I was there."  The patient was therefore left to wonder whether the radiologist's reading of the current images was likely to have been less than thorough.  Had the doctor been diagnostically anchored by reviewing the 2009 test results, or was she able to put those results aside and view the new images without prejudice? Our patient now feels that she has to request a second reading by another doctor.

I'm sure that the doctor did not mean to raise these doubts by her comments, but we need to understand that when a woman is asked to have breast imagery done, she is likely to be quite sensitive to the choice of words used by the clinical staff.  Here, instead of offering reassurance in the face of negative images, the doctor's remarks managed to cause the patient unnecessary concern.

eJournal Club - Session length and weight gain

This month's eJournal club concerns a paper published by a fellow from our institution that attempts to get to the bottom of an interesting question: in patients with a high interdialytic weight gain (IDWG), is the dialysis session length (DSL) or the total volume gained more important? Both of these have been associated with increased mortality and both lead to an increased ultrafiltration rate (UFR). However, because they are interrelated, it is difficult to say which is more relevant.

For this study, the authors looked at more than 14,000 patients attending dialysis in the US. They excluded patients at extremes of session lengths and those who did not gain any weight between sessions. Patients with a URR less than 65% were also excluded to rule out any effects of underdialysis. The mean IDWG and DSL over 30 days were chosen as the exposures of interest. Interestingly there was high correlation between the 30-day IDWG and DSL and the 60 and 90-day means. The outcome was death from any cause. For the purposes of the analysis, the participants were divided into 2 groups for each exposure - less than or greater than 3kg IDWG and less than or greater than 240 minutes for DSL. A matched case-control study design was used.

Not surprisingly, the patients with higher IDWG tended to be younger, male, AA, had higher blood pressure and a higher prevalence of diabetes and CHF. Patients with lower DSL were more likely to be female, older and were less likely to have diabetes, CHF and CAD.

For the DSL analysis, lower DSL was associated with a HR of 1.32 (1.03-1.69) for mortality after full adjustment. For the IDWG analysis, increased IDWG was associated with a HR of 1.29 (1.01-1.69) for mortality. Thus both DSL and IDWG were independently associated with mortality.

What does this study mean for clinicians. It suggests that targeting both of these interventions could be useful. However it should be pointed out that this is an observational study and that they could not show that changing any of these exposures changed risk. Also, the because of the study design, the authors can only state conclusively that both are associated with mortality and not which one is more important. These conclusions may seem obvious but it is important to have good evidence to present to patients who may be frustrated with our requests to increase times and reduce fluid intake.

Head over the eJournal Club to continue the discussion of this paper.

From MIT: Designing and Operating Safety Systems

Designing and Operating Safety Systems: The Missing Link

MIT SDM Systems Thinking Webinar Series

SDM alumnus John Helferich, former senior vice president of R&D, Mars Inc., and Ph.D. student, MIT Engineering Systems Division
Date: July 29, 2013
Time: Noon – 1 p.m. EDT
Free and open to all Register

About the Presentation

Hospital safety, aviation safety, food safety, product safety and virtually any safety system designed to prevent injury or death, share a critical, often overlooked component: the people who design, operate, and manage them. Recent research shows that they often make mistakes because they are rarely considered part of the system.
This webinar will address why and how to incorporate "safety of management" to minimize errors. It will cover:

• examples of safety failures and high-level analyses of their origins;
• a description of the STAMP (Systems Theoretic Accident Model and Process) model developed by MIT Professor Nancy Leveson and described in her book, Engineering a Safer World (MIT Press, January 2012);
• ways that managers can use STAMP's hazard analysis methods to make safer decisions; and
• mitigation strategies for unsafe managerial decisions.

Webinar attendees will gain a preliminary understanding of how to apply systems thinking to incorporate STAMP and improve safety, no matter what the industry.

About the Speaker

John Helferich has 28 years of experience with every phase of R&D in the food industry. He has expertise in innovation, technical leadership, fundamental research, intellectual property, quality assurance and food safety, external advisory boards, and product development. He founded and led Mars' Cocoa Sustainability Programs and is an expert in the strategic assessment and management of technology and innovation in the food industry.

About the Series

The MIT System Design and Management Program Systems Thinking Webinar Series features research conducted by SDM faculty, alumni, students, and industry partners. The series is designed to disseminate information on how to employ systems thinking to address engineering, management, and socio-political components of complex challenges.

Parsing the rankings: More foolishness

Everybody in the industry knows that the rankings prepared by US News and World Report are so flawed as to be meaningless with regard to the things that patients should actually care about.  But each year, hospital PR flacks are given the assignment of describing the latest rankings in a manner that hospital administrators, doctors, and trustees will find satisfying.  US News aids and abets this by providing lots of kinds of rankings, for the hospitals overall, but also for individual specialties.  Even if you don't make the top ten or top 50 overall, you can brag that one or more of your specialties made the top ten.

I heard one such description this morning on our local public radio station.  For years, Boston Children's Hospital has been in a see-saw battle with Children's Hospital of Philadelphia for the coveted number one national ranking.  CHOP won this year.  You'd never know that from the radio ad, though, which stated that BCH has "the largest number of number one rankings" in the US News edition.

Truly, this is pure silliness.  Both institutions are superb, with thousands of committed clinicians and very satisfied patients and families.  Why they feel the need to parse the US News rumors in such a manner as to draw a distinction is beyond me. 

I'm more impressed with hospitals like Children's Mercy in Kansas City, which are engaged in the kind of transformational change that has brought about significant improvement in quality and safety and promises to do more so.

I'd also rather hear about what CHOP and CHB are doing together to improve the quality of care.  In that category, the Ohio childrens hospitals are truly number one. As I have noted:

Now comes a group of children's hospitals that has established a truly audacious goal -- eliminating all serious harm in Ohio’s children’s hospitals.  The coalition, called Solutions for Patient Safety, is described here.  Their vision is to make Ohio the safest place in the nation for children's care.

I can't begin to tell you how exciting and admirable all this is.  These folks are adopting, in a collaborative learning environment, audacious goals, process improvement techniques from other industries, and transparency of clinical outcomes.  There is nothing they are doing that every hospital in the country cannot adopt -- given sufficient leadership.  There is nothing they are doing that cannot be accomplished by consortia of hospitals in other regions.  They are not being forced to do it by government regulators or insurers.  They are doing it because they want to hold themselves accountable to the standard of care in which they believe.

Now, that's noteworthy!

Hospital slumlord

Miles Moffeit @milesmoffeit in the Dallas Morning News has published an astounding story about a doctor who operated a chain of dangerous Texas hospitals for the last four years despite repeated warnings he was engaging in fraud and putting patients at risk.  Here's the lede:

The physician swept into Terrell as a savior, rescuing its only hospital from bankruptcy. It was the summer of 2008, and Dr. Tariq Mahmood, a specialist in buying financially ailing hospitals, maneuvered swiftly to lay down the favored bid. Not everyone was swooning, however. As Mahmood took over Renaissance Hospital Terrell, employees grew alarmed by his practices. At least one hospital official alerted authorities. But her complaints went nowhere. It took regulators more than four years to rein in Mahmood. Before they acted, he allegedly submitted more than $1 million in fraudulent billings to the government, and substandard care at his chain of small-town Texas hospitals led to multiple patient deaths.

It is not that things went unnoticed:

In those initial days at Renaissance Terrell, patient quality director Edwina Henry says, she witnessed several threats to patient safety. Physicians whose backgrounds had not been vetted were treating patients. An ER doctor forced to work 24-hour shifts kept falling asleep. Unsupervised nurses retrieved patient medications from the unattended pharmacy. Henry also watched Mahmood thumbing through other doctors’ patient charts and writing in them — making what she feared were fraudulent entries aimed at boosting insurance billing revenue, she said. “He was adding conditions to the patients’ charts — things that were supposedly wrong with them,” Henry said. “He wrote whatever he pleased.” Henry secretly alerted authorities to the potential fraud and to the safety threats. But her warnings generated no effective response. 

I'll leave the rest for you to read. To provide an tease, I include Miles' final listing of issues in these hospitals:

AT A GLANCE: Four years of trouble

Since 2008, Dr. Tariq Mahmood’s hospital chain has regularly run afoul of dozens of regulations.

Summer 2008: Mahmood takes control of bankrupt Renaissance Hospital Terrell. The patient quality director alerts health care regulators and criminal investigative agencies to potential billing fraud and patient safety threats. No agency follows up with her.

April 2009: Regulators with the U.S. Centers for Medicare & Medicaid Services and the state health department cite Renaissance for turning away patients, an alleged violation of the federal Emergency Medical Treatment and Active Labor Act, or EMTALA. That month, authorities cite Lake Whitney Medical Center for the same problems.

July 2009: Regulators again hit Lake Whitney with an EMTALA violation.

December 2009: Regulators cite Shelby Regional Medical Center for violating EMTALA.

January 2010: Inspectors find rusty “over-the-bed tables” in patient rooms at Lake Whitney and other substandard building conditions that put patients at risk.

February 2010: Regulators cite Renaissance again with an EMTALA violation.

July 2010: At Cozby-Germany Hospital, inspectors flag failures to vet credentials of doctors and nurses. Over the next three years, several of Mahmood’s hospitals are repeatedly cited for similar violations.

September 2011: At Renaissance, inspectors document that a bungled blood transfusion procedure was performed without supervision of a registered nurse.

October 2011: At Shelby, inspectors document broken air conditioning and failures to prevent ceiling plaster from falling into the patient food service line.

June 2012: The Texas secretary of state revokes Renaissance’s business charter for failure to pay taxes.

September 2012: The state health department notifies Renaissance that it is proposing a $35,050 fine for 13 care violations such as nursing supervision failures dating as far back as 2010.

December 2012: As surveyors inspect Shelby, the power goes off to the complex’s buildings, except for the main hospital. The electric bill and other debts amounting to nearly $200,000 haven’t been paid, they report.

January 2013: Inspectors respond to complaints at Renaissance and document three ER patient deaths they say resulted from nursing supervision breakdowns.

February 2013: The state health department is in the process of revoking Renaissance’s operating license. The Centers for Medicare & Medicaid Services terminates funding to Renaissance. It takes local governments to force the immediate closure of the hospital because of unpaid taxes.

July 2013: CMS moves to terminate Shelby’s funding following the death of an ER patient. The death is blamed on nurses’ inability to get the ER doctor to leave the “sleep room.”

The potential danger in treating Hypothermia-induced Hypokalemia

The post from Veeraish earlier this week reminded me of this patient who demonstrated an important learning point regarding hypokalemia in hypothermic patients. A 75 year old woman was found unconscious in her unheated home with overnight temperatures of -1⁰C. On arrival at the Emergency Department, her core rectal temperature was a staggering 21⁰C, blood pressure 90/50 and pulse was 28 beats per minute. EKG was classic, demonstrating slow atrial fibrillation, wide T wave inversion and the characteristic J waves of hypothermia (see Figure; note that the depth of the J wave inflection correlates with the degree of hypothermia). Laboratory values included  serum potassium of 1.1 mmol/L, phosphorous <1 mg/dl, pH 6.95, lactate 8.5 mmol/L, glucose 522 mg/dl. Her renal function was normal. After some initial warming, repeat potassium was 1.6 mmol/L and her heart rate improved. When she had been warmed to 26⁰C, the serum potassium corrected to 5.1 mmol/L before settling at 3.6 mmol/L (with no potassium supplementation). Her serum phosphorous level and blood sugars normalized when her body temperature rose above 30⁰C. She also spontaneously converted to sinus rhythm. 

This case illustrates the profound metabolic complications which can arise in the context of extreme hypothermia. Hypokalemia is well recognized in hypothermia, however, the drop in serum potassium levels is usually mild. Most reported cases involve intentional body cooling in treatment of severe head injury or post-cardiac arrest. The mechanism of hypokalemia is thought to be redistribution of potassium back into the cell. As mentioned by Veeraish, a case has been bravely described of a patient developing hypothermia-associated hypokalemia while being intentionally cooled after head injury. Treatment with potassium supplementation and re-warming occurred concurrently and the patient then suffered a fatal arrhythmia. As the serum potassium will correct itself with rewarming, we should be extremely cautious about administering potassium to hypothermic patients due to the risk of severe rebound hyperkalemia.

Doing poorly on wellness

I have the highest regards for Diane Rehm and her radio show, which originates at WAMU and is syndicated nationally.  How disappointing, then, to listen to her recent show, "Wellness Programs in the Workplace."  Much of the show was based on unsupported assertions about the value of wellness programs.  Statistics were bandied about with little plausibility, starting with this particularly meaningless and unprovable one:  "Forty percent of Americans die prematurely."

As radio, too, it was uninteresting, with no one invited to present the other side.  For example, they might have invited Tom Emerick or Al Lewis, whose recent book Cracking Health Costs sets forth the methodological flaws used by those who will try to convince you that prevention and wellness companies will save your company money.

In one segment of the radio show, mention was made of the C. Everett Koop Award, given for promoting better health while cutting medical costs.  But no one mentioned the controversy surrounding one of the awardees, the state of Nebraska.  The Nebraska state employee wellness program had said it saved $4.2 million, caught more than 500 early cancers and improved the health of thousands of employees in its first two years.  But, on July 15, the Omaha World-Herald published a story reporting that Al Lewis had found methodological flaws in their data.  He said,  “The bottom line is their numbers don't add up."

The article noted:

State Auditor Mike Foley also has been skeptical of the savings reported for Nebraska's wellness program.  In an audit last year, he called for the state to analyze whether the program's financial benefits outweigh the added administrative costs. 

Lewis and his colleagues believe the Koop award committee should rescind the award.  They state:

The state of Nebraska and their vendor, Health Fitness Corporation, lied about their cancer incidence late, claiming 514 "life-saving catches" of people with cancer, that were also "cost-saving," in order to get more state funding and public support. It turns out that almost all of these people did not have cancer, but only benign polyps that many adults of a certain age get. A few turn into cancer, just like a few people with high cholesterol get heart attacks, but to call these cases cancers and take credit for "life-saving catches" is a lie, equivalent to saying that people with high cholesterol had heart attacks.

They point out that the state claimed $4.2 million in savings even though only 186 people's risk declined, and claimed a 3% reduction in use of chronic disease medications even though they diagnosed an extra 40% of the population with a chronic disease needing medication.

Here's hoping Diane Rehm will revisit the issue on her radio show and that other commentators, too, will offer a more balanced view of these matters.

Renal Jeopardy

Icahn School of Medicine at Mount Sinai are organizing a CME event: "Contoversies in Kidney Disease" aimed at attending nephrologists and fellows on September 13th 2013. This course will cover a broad range of topics of interest to nephrologists including cardio-renal issues, vitamin D and cardiovascular disease, genomics and IgA nephropathy. They have a great group of invited speakers.

In order to sweeten the deal for fellows, the registration fee will be $25 for trainees and there will be a special Renal Fellow Jeopardy Contest during lunchtime.

Integrating mind and body health on WIHI

The next WIHI broadcast will take place Thursday, July 25, 2013 on Integrating Physical and Behavioral Health – Illustrations from the Frontlines, from 2 to 3 PM ET.

Our guests will include:

• Benjamin Miller, PsyD, Assistant Professor and Director, Office of Integrated Healthcare Research and Policy, University of Colorado Denver
• Brenda Reiss-Brennan, PhD, APRN, CS, Mental Health Integration Director, Primary Care Clinical Programs, Intermountain Health Care
• Mara Huberlie, MA, Director of Project Implementation & Continuing Education, Greater Nashua Mental Health Center
• Melissa Merrick, LCSW, CDC I, Administrator/BHC Clinical Supervisor - Medical Services Administration, Southcentral Foundation

The road to recognizing the impact of mental illness on the lives of patients and families, and society as a whole, has been an uneven one in the US. Even as battles are being won for benefit parity, and medications can now alleviate some of the worst suffering, the stigma of suffering from depression or some form of psychosis still has a lot of staying power. And most experts agree the supply of mental health professionals doesn’t begin to match the numbers of people in need of therapy and treatment. 

Against this backdrop, a new approach is emerging to bring mental health “in from the cold.” Our upcoming July 25 show, Integrating Physical and Behavioral Health – Illustrations from the Frontlines, will showcase leaders and organizations that are at the forefront of redesigning care for patients and populations in need of primary care and mental health services. By offering both, often in the same location, providers are more likely to help their patients connect the dots between body and mind, and improve underlying health problems in a more holistic fashion. Research has begun to demonstrate that this approach leads to improved chronic conditions and fewer trips to the ED.

However, just because something makes a lot of sense doesn’t mean there’s the infrastructure, the clinical training, or the payment system to effect these changes. That’s where places like Intermountain Health Care, Southcentral Foundation, and Greater Nashua Mental Health can be especially helpful: they’ve forged ahead with new models and hope that others can learn by their example. Ben Miller has that big picture, and when combined with the expertise of Brenda Reiss-Brennan, Mara Huberlie, and Melissa Merrick, the July 25th WIHI promises to be jam-packed with new ideas and thinking.

You can enroll for the broadcast here.

GiveForward helps with patient finances

What ActBlue does for political fundraising, what Kickstarter does for new ventures, GiveForward does for needy patients and families.  The idea is that you create a fundraising webpage for someone you care about, publicize its existence through your social media networks, and people who are moved contribute. The site takes a modest handling fee.

To date, the site has raised over $53 million for patients' medical bills and out-of-pocket expenses.

An interesting question is whether directors of revenue integrity and CFO's of major hospitals would be interest in adopting the platform as a free, add-on service on their hospital websites.  One hypothesis is that doing so might increase patient satisfaction and help recover more money from self-pay patients.  Another is that it would be viewed as self-serving and tacky, rather than altruistic.  If you are in an administrative capacity in a hospital, please send your thoughts on this question. Would this be interesting to you?

Infrastructure, blame, and the Vasa

My blog post on Saturday about a street renovation project in my community appears to have stimulated a lot of response in town, including on this local blog.  I understand that the actual disposition of the project remains in doubt.  Once that is resolved, there will be the inevitable and unfortunate exercise about whom to blame.

My regular readers know how I feel about blame.  It is usually unproductive and often serves to mask underlying systemic problems or leadership failures in an organization.  In addition, the wrong person--often the one with the least power in an organzation--is likely to be unfairly blamed.

Counter examples are powerful.  I often tell the story of Tom Botts from Royal Dutch Shell, who commented about deaths on one of his company's oil rigs:

It was a defining moment for us when we, as senior leaders, were finally able to identify our own decisions and our own part in the system (however well intended) that contributed to the fatalities. That gave license to others deeper in the organisation to go through the same reflection and find their own part in the system, even though they weren’t directly involved in the incident.

But the body politic sometimes insists on assigning blame when there has been an embarrassing failure.  The story of the Swedish ship Vasa provides an allegory.  Wikipedia explains:

Until the early 17th century, the Swedish navy was composed primarily of smaller single-decker ships with relatively light guns; these ships were cheaper than larger ships and were well-suited for escort and patrol. However, a fleet of large ships was considered a bold statement and an effective way to impose respect on enemies and allies alike, possibly even beyond the Baltic. For the ambitious [king] Gustavus Adolphus, a navy with a core of powerful capital ships was an opportunity that could not be missed. Vasa was the first in a series of five ships intended to be among the heaviest and most splendid of their time. 

During the design and construction of the ship, the king demanded many changes in its size and other characteristics.  The result was that it became unstable.  On its maiden voyage on August 10, 1628:

Vasa sank in full view of a crowd of hundreds, if not thousands, of mostly ordinary Stockholmers who had come to see the great ship set sail. The crowd included foreign ambassadors, in effect spies of Gustavus Adolphus' allies and enemies, who also witnessed the catastrophe.

The king was notified by letter of Vasa's fate on 27 August. "Imprudence and negligence" must have been the cause, he wrote angrily in his reply, demanding in no uncertain terms that the guilty parties be punished.

In what seems comical today but at the time was deadly serious, this sequence followed:

Captain Söfring Hansson, who survived the disaster, was immediately imprisoned awaiting trial. Under initial interrogation, he swore that the guns had been properly secured and that the crew was sober. Surviving crew members were questioned one by one about the handling of the ship at the time of the disaster. However, no one was prepared to take the blame. Crewmen and contractors formed two camps; each tried to blame the other, and everyone swore he had done his duty without fault. Later, the focus was turned on the ship builders. "Why did you build the ship so narrow, so badly and without enough bottom that it capsized?" the shipwright Jacobsson was asked by the investigators. He fell back on the classic strategy of civil servants; he had simply followed orders. Jacobsson stated that he built the ship as directed by [his predecessor and mentor] Henrik Hybertsson (long since dead and buried), who in turn had followed the instructions of the king.

In the end, no guilty party could be found.  After all, who could blame the king?

Some of my best friends are anaesthesiologists

This column is prompted by a recent Twitter conversation that was part of a thread based on a previous blog post in which I contrasted the systems approach used for airline safety with the lack of same in many hospitals.  Warning:  You are about to read gross generalizations and stereotypes!

Carolyn Johnston, @DRCJohn, and Barbara Nelson, @SafetyNurse, made the point:

Aviation emulated successfully in anaesthesia, w 1 of best #ptsafety records http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1117775/ …”

This prompted me to ask:

Yes, anaesthesia has led the safety movement--so why can't they help eliminate wrong site surgeries?

Perhaps it is because they are not attuned to crew resource mgmt and how to bring it abt in the ORs.

Perhaps they are overly deferential to the surgeons & revert to passivity in the face of aggression.

To which Dermot O'Riordon, @dermotor, (Surgical/Med Director in Suffolk, UK) replied:

"Overly deferential to surgeons"? You must know v different anaesthetists to those I work with!

I was being lighthearted in my last comment, but a serious question remains, and I'd like to use this post to challenge anaesthesiologists out there to give a good answer.

As I noted above, anaesthesiologists have led the safety movement in hospitals.  They introduced many innovations into their own practice--in terms of procedures, equipment safety, and simulation training.  I have found them, too, to be devoted to the science of process improvement, both in operating room settings and in critical care.  I've also found them to be modest about what they know and what they don't know, always looking to improve their own skills and the work environment.  Finally, many are excellent teachers.  In short, an exemplary group of doctors.  Indeed, they have gotten so good at what they do and cause so little harm that malpractice insurance rates for the profession have dropped and are quite reasonable compared to other specialists.  As noted here:

Decreasing anesthesiologist malpractice premiums reflect the decrease in the number of catastrophic anesthesia claims for esophageal intubation, death, and brain death.

In 1985, the average malpractice insurance premium was $36,224 per year for a $1 Million per claim/$3 Million per year policy.   By 2009, this decreased to $21,480, a striking 40% drop.

The take-home message is that anesthesia has serious risks, but those risks have decreased significantly in recent years because of improvements in monitoring and education.  Compared to other specialties, the risk of an anesthesiologist being sued is about average among American medical specialties.

Notwithstanding that, as we have discussed, the number of wrong site surgeries and other procedures in the US remains remarkably constant.  There is a clear pre-surgical protocol that is well developed that should be followed in every case to prevent this, but it is not always followed. As I noted:

The simple truth is that many doctors don't buy in to this.  I've heard of some anaesthesia writings that cite the statistics indicating the errors continue as evidence that the checklist protocol does not work!  These observers completely ignored whether the protocol was actually being followed or not.

My question is this:  Recognizing that the surgeon is the "pilot of the ship" in the OR, the anaesthesiologist has a critically important role in every case.  Why isn't this profession taking on the advocacy role for full and complete implementation of the pre-surgical checklist?  Beyond this, why doesn't this profession insisting on teaching crew resource management in the high pressure surgical environment.  In short, why isn't anaesthesia as a profession driving the broader kind of process improvement for which it has become legend in its own arena?

Standing by for your answers.

Hypothermia Protocol and Dialysis

I recently received an inpatient consultation to see a CKD 5D patient. The reason for consult, as is mostly the case with dialysis patients was that he “needs hemodialysis”.

This dialysis patient wasn’t the average bear though. He had had a witnessed cardiac arrest, was treated by EMS, and defibrillated. He had a return of spontaneous circulation after being pulseless for 20 minutes. As soon as he got to the ER, he was initiated on our standard institutional therapeutic hypothermia protocol.  I was called in to dialyze him because (it wasn’t his usual day) the cardiologist wanted to perform a left heart cath on him the following day, and they “did not want dialysis to interfere with that schedule”. My clinical assessment did not reveal a severe degree of volume overload. He wasn’t hyperkalemic, and had only a mild degree of lactic acidosis that was nicely compensated by him being appropriately ventilated. Due to the concerns that I talk about below, I did not see an emergent reason to dialyze him.

I would like to focus on a few teaching points from a nephrologist’s perspective that I took away from this scenario:

1. Therapeutic hypothermia entails cooling post cardiac arrest patients to 32-34 degrees Celsius, ideally within 6 hours of a cardiac arrest.  Both intravascular and surface cooling methods are used. At my institution, the protocol involves administering up to 3 liters of 0.9% saline (which has been cooled to a temperature of 4 degrees Celsius), over an hour. This is complemented by cooling vests. Once target temperature is reached, the cooling phase is continued for 12-24 hours, after which the patient is rewarmed gradually at the rate of 0.5 degrees Celsius/hour.
2. Sub-physiological body temperatures expectedly have adverse effects. Hypothermia can hamper leukocyte function, increasing infection risk later. Cardiac effects include bradycardia and prolonged QT interval (both were present in this patient). Finally, for us nephrologists, here are some adverse effects and pertinent points that we need to keep in mind for such patients:
3. Hypothermia can cause hypokalemia via two different mechanisms. Low temperature causes a transcellular shift of potassium in to the intracellular compartment. This effect is possibly mediated by increased beta adrenergic and sympathetic activity. In fact, hypokalemia in the setting of hypothermia must be repleted extremely cautiously, if at all, given the risk of rebound hyperkalemia as potassium moves back out of the cells when the patient is rewarmed. This rebound hyperkalemia can be frequently fatal due to arrhythmias.
4. The second mechanism by which hypothermia causes hypokalemia is by the induction of polyuria, also known as “cold diuresis”. This hypokalemia is mediated by increased urinary flow, and is seen in conjunction with hypovolemia, hypophosphatemia, and hypomagnesemia. I didn’t observe any of these in my patient, maybe because of his oligo-anuric status at baseline. Nevertheless, close monitoring of volume status and electrolytes is required.
5. Hypothermia interferes with platelet function and with the clotting cascade. In fact, as per this review, 22% of patients had bleeding post-hypothermia induction. That might be a concern when making the decision to dialyze post-hypothermia patients with heparin.
6. The other issue that I ran in to, that was specific to dialysis patients, was the concern about the patient’s temperature. As we know, most HD machines warm blood before returning in to the patient. With most machines, the warmer cannot actually be turned off and only goes as low as 35 degrees Celsius. In other words, dialysis can inadvertently warm the patient up to this temperature (from the target temp of 32 degrees, per the hypothermia protocol)! CRRT machines do have adjustable temp settings that goes down to 32 degrees, so that might be a safer alternative. Given the risk of inadvertently warming the patient, and because I did not see any emergent indication for dialysis, I did not dialyze the patient. I believed that in that situation, his hypothermia protocol took precedence over dialysis.

In my experience, I have observed that referring non-renal physicians often consider inpatient hemodialysis an ancillary service, akin to placing an order for an x-ray or a lab draw. Seasoned fellows have heard this phrase all too often, “I want you to come down and dialyze this patient”. You are then left with the unenviable task of explaining to the non-renal physician that the decision to dialyze would be made by the nephrologist after proper assessment of the patient (isn’t why they consulted you in the first place?). Let’s not allow our familiarity and comfort with dialysis technology lull us in to putting our guard down. Dialysis is an inherently intense and complicated procedure where multiple clinical parameters need to be closely watched. It’s a fact that is often lost in translation.

Posted by Veeraish Chauhan

Who decided this?

Why is it that @Amtrak @AmtrackNEC required my 15-year-old cousin to be registered as an unaccompanied minor when airlines allow people much younger traveling alone not to be? Luckily, we had walked him to the train and were there to fill out the form. Otherwise, he would have missed his train.

Here are the rules and regulations and instructions for filing out the form.  A lawyer's dream!

And here is the form itself.  Among other things, you need to certify that the passenger "does not have any life-threatening food allergy, such as an allergy to peanuts or peanut products."

The power to persuade

“It must be remembered that there is nothing more difficult to plan, more doubtful of success, nor more dangerous to manage than a new system. For the initiator has the enmity of all who would profit by the preservation of the old institution and merely lukewarm defenders in those who gain by the new ones.”
― Niccolò Machiavelli

This quote is prompted most immediately by comments I received on a recent blog post with regard to a minor infrastructure project in my home town.  But it is something I have been wanting to discuss for some time.  Over the last several years, we have seen new executive leadership at the national, state, and local governmental level characterized by well-intentioned, thoughtful, and intelligent people, some of whom have not been able to build and manage constituencies to support their agendas.  It is not that these folks fail to understand marketing and persuasion: Indeed their election campaigns are models of grass-roots outreach and popular appeal, often artfully tapping the power of social media.  The issue is that they don't understand that governing requires a very different set of skills.  Once you are actually in charge, decisions you make will, as Machiavelli noted, arise the ire of those opposed, while those who are in favor tend to sit on the sidelines.  So your job has to include maintaining and building a sufficient base of support to offset the ability of individuals to create blocking coalitions.

Richard Neustadt wrote about this in 1960 in his book Presidential Power.  The book focuses on  the Presidency, but it applies as well to governors and mayors.  Let me borrow some summaries from Wikisummary:

Neustadt uses a pluralist view to understand politics. In the pluralist world, competing factions mobilize and counter-mobilize, persuading and arguing until policy ultimately arrives at what the typical citizen would want.

"Presidential power is the power to persuade." Presidents are expected to do much more than their authority allows them to do. Persuasion and bargaining are the means that presidents use to influence policy. 

"Effective influence for the man in the White House stems from three related sources: first are the bargaining advantages inherent in his job with which to persuade other men that what he wants of them is what their own responsibilities require them to do. Second are the expectations of those other men regarding his ability and will to use the various advantages they think he has. Third are those men's estimates of how his public views him and of how their publics may view them if they do what he wants. In short, his power is the product of his vantage points in government, together with his reputation in the Washington community and his prestige outside. 

"A President, himself, affects the flow of power from these sources, though whether they flow freely or run dry he never will decide alone. He makes his personal impact by the things he says and does. Accordingly, his choices of what he should say and do, and how and when, are his means to conserve and tap the sources of his power. Alternatively, choices are the means by which he dissipates his power. The outcome, case by case, will often turn on whether he perceives his risk in power terms and takes account of what he sees before he makes his choice. A President is so uniquely situated and his power so bound up with the uniqueness of his place, that he can count on no one else to be perceptive for him."

I wonder if some members of the new generation of political leaders are so seduced by the effectiveness of their campaign methods--and the warm feeling that comes from being adored by your supporters during an election--that they have failed to move along to the next step, learning how to build and maintain the constituencies that are needed to govern.

Hey, that was our money!

What's worse than making an infrastructure decision without sufficient public input? Undoing the change before it has had a chance to be properly tested.  Boston.com reports:

The city of Newton is reversing course and undoing some modifications recently made at a busy intersection in Newton Centre, after discovering the changes had made traffic worse, not better. 

The city attempted to speed traffic flow through the congested intersection of Parker and Cypress Streets at Centre Street by narrowing the lanes and adding a stop sign, but the new modifications have created more backups, said Commissioner of Public Works David Turocy. 

As early as next week, workers will start undoing the modifications to return the intersection to its old configuration.

I think there is an unreported back story:  This is government at work in an election year.  Many of my friends and neighbors complained to the Mayor's Office about the change and the politically correct administration decided to cave.   (I actually found that the intersection worked better with the change.)  Why did they complain?  First, the reconfiguration required a small change in driving habits. (Previously, traffic entering from Centre Street would have to yield. Now, the traffic from Cypress Street would have to yield.)  Second, the road is still roughed up, without final paving, and traffic slows because of that. Third, the temporary signage at the intersection is not optimal.  People are not yet used to the change, and so the improvement in traffic flow that was envisioned has not yet been achieved.

Most importantly, though, there was insufficient public consultation and communication during the design process.

By the way, there was a logic to the change.  In a guest column in the local paper, the chair of the mayor's Transportation Advisory Group and the Pedestrian Coordinator noted:

The reconfiguration . . .was implemented to reduce crashes between vehicles and normalize it with other intersections (taking away the left-turning priority and giving the right of way to the through traffic.)

These behaviors lead to the kind of pedestrian crashes we see across the city including the two in newton Centre in November, when elderly Newton residents were hit in two separate incidents.

. . . .The number of legal travel lanes for cars remains the same.

It's hard, though, to sell a project that will save lives because no one can envision the people who have yet to be injured.

Perhaps all of this could have been avoided if there had been a proper public consultation process before the streets were torn up.  Meanwhile, what a waste of money:

The intersection was being remodeled as part of a $1.8-million contract from the state, said Turocy, that included work on two other intersections as well as a street paving. He said he did not know how much the work on Cypress and Centre Streets cost, but that the city had funds leftover in the grant which would pay for the reversal of the construction. 

This makes it sound like the result was costless to the citizenry.  Obviously, that is not so. At a minimum, there was an opportunity cost, in that the funds could have been spent elsewhere. But, also, all of Newton's residents pay state taxes, so that was our money.

Ah, for astonishingly safe!

While there are differences between airline travel and the provision of health care, the one has a lot to teach the other.  Note this interview of Patrick Smith in the New York Times.  Read this description and imagine if the same things were in place throughout the health care system.

Q. You say air travel today is astonishingly safe. Why?

A. We’ve engineered away what used to be the most common causes of catastrophic crashes. First, there’s better crew training. You no longer have that strict hierarchical culture in the cockpit, where the captain was king and everyone blindly followed his orders. It’s team oriented nowadays. We draw resources in from the cabin crew, people on the ground, our dispatchers, our meteorologists, so everyone’s working together to ensure safety. 

The modernization of the cockpit in terms of materials and technology has eliminated some of the causes for accidents we saw in the ’70s into the ’80s. And the collaborative efforts between airlines, pilot groups and regulators like the Federal Aviation Administration and the International Civil Aviation Organization, a global oversight entity, have gone a long way to improving safety on a global level. 

To bring this home:  Poorly designed systems, poorly functioning teams, and work-around laden work flows, aided and abetted by inadequate reporting of adverse events and near misses, kill the equivalent of a 727 jetliner full of passengers every day in America's hospitals.  If this happened for three days in a row in the airline industry, we'd shut down the airports and ground the flights until we figured out what went wrong and how to fix it.

If airlines are astonishingly safe, as suggested by Mr. Smith, hospitals are astonishingly dangerous.  I don't want to believe that the difference is the case because pilots have an additional incentive in that they go down with the ship.  I want to believe that doctors simply don't understand that their pledge to do no harm is not being fulfilled.

Kidney Stones - What's the diagnosis? - Answer

This was an interesting case and all those who responded correctly identified that the patient had bowel pathology. However, only one person figured out that the issue was an ileostomy. This patient had a low urine volume and an extremely low urinary citrate and sodium. The low citrate could indicated a renal tubular acidosis except that the urinary ammonium was high and the urine pH was very low indicating preserved ability to acidify the urine. This points to a metabolic acidosis. The urine sodium in an average US resident is between 100-200 mmol/day. Outside of the amazon, it's hard to imagine that anyone could take in this little salt. This points towards loss of sodium bicarbonate and water from the GI tract.

Finally, in the setting of IBD, generally it is accompanied by hyperoxaluria. There are a number of potential mechanisms for this; decreased metabolism of oxalate by oxalobacter formigenes, decreased calcium binding to oxalate because of the relatively increased binding of calcium to malabsorbed fat in the GI tract. In any case, in order to have hyperoxaluria, it is necessary to have a functioning large bowel. In this case, the patient's urinary oxalate was 28 which is in the low normal range and not suggestive of hyperoxaluria. Thus, the diagnosis is high output of alkaline fluid from an ileostomy.

The treatment in this case is to increase fluids and treat with a combination of sodium and potassium citrate. Even a small rise in urine pH would significantly reduce the risk of uric acid stones while the citrate and increased volume should reduce the calcium oxalate stone risk.

When the rulebook has no remedy

@BradleyFlansbau, Brad Flansbaum, over at The Hospital Leader offers thoughtful comments about the ambiguities in near-death situations in hospitals. He points out the inherent flaw with advance directives:

You realize that even with the indecision of how our country will manage end of life care and the calls for greater engagement from our citizenry, no piece of paper will resolve certain impasses.

I will offer the following:

Advance directives simply promise more control over future care than is possible. We also cannot predict our preferences as our health states evolve and possibly worsen.

So true, and Brad's article is an excellent exposition on the topic, presenting two "bookend" cases on the matter.

But, let's recall the work of Bernard J. Hammes, director of Medical Humanities and Respecting Choices at Gundersen Lutheran Health System, who edited the book, Having Your Own Say. In my review of the book, I said:

If I were to simplify the theme of the book, it is that advanced directives (ADs) are insufficient when it comes to end-of-life planning.  Drawing on the experience of the GLHS and other places, the book demonstrates the importance of an ongoing process for advance care planning (ACP).

So, while nothing can undo the conclusions reached by Brad, the insight offered by Hammes is that we can at least do better in keeping our end-of-life wishes as up to date as possible.

Nonetheless, as Brad notes:

No advance planning can prevent a Mr. Brown or Dr. DeBakey from presenting to your hospital.  We can only write about their (and our) plights to provide comfort for the times we look in the mirror for solutions.  When the rulebook has no remedy and the right path seems more like the roll of a dice than an ordered prescription, we hope for the best and absorb whatever lessons these unfamiliar cases can teach us.

This kind of  intellectual and emotional modesty is, in my mind, the sign of a great doctor. In contrast, s/he who is overly confident in these matters is delusional and empathetically deficient.