Knowing when it's time to leave

Please check out this autobiographical new post over at the athenahealth Leadership Forum.  Comments welcome there or here.

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How is it different?

Rosemary Gibson--author of The Treatment Trap--offered a trenchant comment on a ProPublica story by Charles Ornstein about how the University of Illinois violated its own policies by endorsing the product of a medical device company:

Okay, so in Europe, when device maker J&J paid doctors who are government employees to use J&J products, the DOJ and SEC called it bribery and a violation of the Foreign Corrupt Practices Act. J&J paid $70 million in fines and the SEC expressed concern about the public health of people in European countries. Why not here?

I looked into the case cited by Rosemary.  Here's the summary of the charge and the disposition. An excerpt:

The SEC alleges that since at least 1998, subsidiaries of the New Brunswick, N.J.-based pharmaceutical, consumer product, and medical device company paid bribes to public doctors in Greece who selected J&J surgical implants, public doctors and hospital administrators in Poland who awarded contracts to J&J, and public doctors in Romania to prescribe J&J pharmaceutical products.

Cheryl J. Scarboro, Chief of the SEC Enforcement Division’s Foreign Corrupt Practices Act Unit, added, “Bribes to public doctors can have a detrimental effect on the public health care systems that potentially pay more for products procured through greed and corruption.”

Ok, the case differed a bit from the US environment:

J&J subsidiaries, employees and agents used slush funds, sham civil contracts with doctors, and off-shore companies in the Isle of Man to carry out the bribery.

But the question Rosemary correctly asks is whether the J&J payments are equivalent to payments by other companies to public doctors and institutions in the United States.  The University of Illinois doctors who have been receiving financial support from Intuitive Surgical, Inc. are public employees.  Do we have any doubt that such a financial relationship influences the treatment patterns of those doctors?  Do we have any doubt that it has influenced equipment purchase decisions by this public entity (over $4.5 million in FY 2012, FY 2013, and half of FY 2014)?  Do we have any doubt that there is an incomplete disclosure to patients of the relative risks of robotic surgery compared to manual laparoscopic and open surgery at UIC? Shouldn't we make the logical leap that there is a "detrimental effect on the public health care system" when it comes to at least some of the Institute of Medicine's six domains of quality--safe, effective, patient-centered, timely, efficient and equitable?

I get the feeling that the folks at the University view this episode as over, a slightly embarrassing stain on the institution.  If so, I fear they underestimate the national degree of interest in this topic.  When the first "Sunshine Act" reports are made public in the coming months, we will see every form of payment made by Intuitive Surgical to the faculty of the University.  And to the faculty of every other public institution.

In the meantime, I am issuing a request to my readers:  If you know of faculty members of public institutions who have received payments from this company, would you please submit a comment with their names and, if possible, a publicly available site where I can confirm the matter?  I will not publish the comments, but I will use them for further research by me and also forward them to interested reporters in those jurisdictions.

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No coaches for doctors?

I was re-reading a portion of Atul Gawnde's book Better: A Surgeon's Notes on Performance and was struck by a couple of sentences in the afterword:

Ours is a team sport, but with two key differences from the kinds with lighted scoreboards: the stakes are people's lives and we have no coaches.  The latter is no minor matter.  Doctors are expected to caoch themselves. We have no one but ourselves to lift us through the struggles.

I imagine this is a widely held view, as Atul is a gifted observer of the conditions within which doctors work.  But what a tragedy if the statement is true or if doctors believe it to be true.

If it is is true that doctors have no coaches, that represents an utter failure of the profession.  After all, there are people throughout a doctor's development and career who could serve as coaches--teachers, colleagues, chiefs of service.  Is Atul saying that none of these people view it in their role to be coaches for their students or colleagues?  If so, what a terrible indictment of the profession.

But there are also those in ancillary services like nursing and social work, and, yes, even administrators.  Beyond that, there are lay people who could often play this role--spouses, friends, clergy, and the like. Is Atul saying that doctors do not view it as possible that these people could serve as coaches? If so, what an unnecessarily lonely life must these people live.

All of this reminded me of a portion of this week's letter from my pal Gene Lindsey, in which he quotes a note to him from Rob Jandl, the CMO of Southboro Medical Group,

I have thought too about . . . the non-humane medical system we work in that does not support reflection, or personal growth, humility or even curiosity. Far too many physicians end up overvaluing their technical proficiency and under-valuing their wisdom, intuition, and compassion. I have concluded that while the system of care and even our training leads us in this direction, it will require significant personal growth not as a doctor but as a human being for the world to be different. A person such as this is frozen emotionally, is deeply disconnected from his feelings, and from what it means to be human. The best path I know of to pierce the fog of disconnection is to go right to our greatest fears and vulnerabilities: death, failure, loneliness.

Every day we have a choice. It is hard to see or feel sometimes but it is always there, and that is the choice to look for the opportunities, the potential good, the upside. But for physicians as individuals currently in practice I believe we must help them go inward, help them to grow as human beings, and the language we use as leaders and the work we do must support that journey which may have its dark moments and its losses.

This sure sounds like a profession in need of serious emotional counseling, or what I would call coaching.  After all, the key to good coaching is empathy.  In his afterword, Atul himself offers some good coaching about things doctors can do to make life better for themselves and their patients.  But both his words and Rob's comment left me deeply saddened.  Why should doctors be trained to believe that they are on their own?  While I understand the need for decisiveness and individual action and responsibility in the face of some clinical emergencies, I do not understand why the profession cruelly puts upon itself the expectation of isolation and a lack of support for the emotional well-being of its members.

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They found a replacement!

My post of March 20 made note of a Seattle doctor who permitted her name and reputation--and that of her hospital--to be used in support of a medical equipment company.  Well, I'm guessing that--for whatever reason--either she or her employer told the company to stop doing that.

Luckily for the sake of American commerce, the company was quickly able to find a replacement.  Now the company's website has the following testimonial:

As in the case of the previous doctor, I have no reason to assume that Dr. Deckers is anything but a competent and caring doctor, but this kind of endorsement raises all kinds of questions.  Has she received financial support from this company, and, if so, has that been disclosed under the hospital's conflict of interest rules?

This company seems to have no trouble finding doctors to endorse its product.  Back in 2011, one of its press releases said:

“The TRUCLEAR System has quickly become the standard of care that women deserve,” commented Robert M. Biter, M.D., founder, Seaside Women’s Health, San Diego, Calif.  “It is a safe and effective way to diagnose and treat causes of abnormal uterine bleeding and risk of pregnancy loss.  TRUCLEAR has truly revolutionized my practice.”

Another from that year noted:

“I am thrilled that Smith & Nephew is introducing the new TRUCLEAR SIM Morcellation Simulator which will enable medical students, residents and practicing physicians to perform virtual hysteroscopic morcellation polypectomies and myomectomies,” said Larry Glazerman, MD, associate professor of obstetrics and gynecology and director of minimally invasive gynecologic surgery at University of South Florida Health. “Since patient outcomes are the most important part of any procedure, it is an incredible opportunity for gynecologists to perfect their technique prior to ever touching a patient.”

And in 2012, we learn:

“The TRUCLEAR 5.0 System combines safety, precision, and ease in the treatment of endometrial polyps and small uterine fibroids,” explains Dr. Charles Miller, Past President of the American Association of Gynecologic Laparoscopists (AAGL) and President, the International Society for Gynecologic Endoscopy (ISGE) in Naperville, Ill. “With this less invasive technology, I am looking forward to using TRUCLEAR right in my office – this is especially ideal for my fertility patients whom I prefer not to dilate.”

Also, in that year:

“With the TRUCLEAR System, I have the confidence to safely and effectively resect submucosal fibroids and endometrial polyps under constant visualization,” says David A. Stone, M.D., FACOG, who practices in metropolitan Detroit. “While using the TRUCLEAR ULTRA, I was able to remove a 2.5 centimeter diameter submucosal fibroid in a matter of a few minutes. Using this system can help preserve a woman's future fertility by minimizing damage to the uterus.”

What is it about these doctors that causes them to publicly endorse the product of a medical device company? Are they so moved by its efficacy that they feel highly motivated to spread the word? Or is there some relationship between them and the company that provides the impetus for such statements?

Why aren't health care journalists on top of every single such case of possible conflict of interest in their community?

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With insurance available, ED visits rise

My friend and colleague Peter Smulowitz and co-authors have documented what many of us noticed anecdotally at the time.  Looking at Massachusetts following the introduction of universal health insurance coverage, they found:

Compared with the 2-year period before reforms started to go into effect, emergency department visits increased by up to 1.2% during the 1-year implementation and by up to 2.2% during the 2-year period after reforms were fully in effect.

The study is in the Annals of Emergency Medicine.  News@JAMA summarizes key points:

The authors analyzed all emergency department visits in Massachusetts between October 1, 2004, and September 30, 2009. The data included records from 69 hospitals, accounting for some 2 million annual outpatient emergency visits, 850 000 inpatient admissions, and 150 000 observation stays. Reforms that expanded health care access in the state were implemented between October 1, 2006, and September 30, 2007.

Several factors drive these trends, the Annals authors wrote. They named transportation, ability to take time off from work or find child care, emergency departments’ 24-hour availability, limited availability of primary care services, distances between the emergency department and a primary care physician, and the perceived efficiency and expertise of emergency departments.

“Our study suggests that other states should be prepared for equal or greater influxes of patients into the [emergency department] after health care reform is fully implemented,” the authors wrote.

Kristin Gourlay, a columnist at Rhode Island NPR, notes:

Another study from Oregon found something similar. So we've got two studies now suggesting that health care reform - the Affordable Care Act, extending health insurance to more Americans - may not necessarily be moving the needle on something we thought it would: reducing the number of costly ER visits made by the uninsured who can't afford care elsewhere. The big hope was that the more people got health insurance, the fewer would need to come to the ER for routine care.

According to these studies, it turns out that it's not just the uninsured who use the ER for health problems that could be taken care of by a primary care doctor or in another outpatient clinic. People with insurance may be using the ER for those kinds of health problems, too. No one's suggesting that there aren't legitimate emergencies represented in this data. But it suggests that people may have been waiting to get some things taken care of, or that they haven't been able to find a regular doctor.

It's not clear to me who had that "big hope."  Many of us projected that the ACA was not likely to lead to bending the curve of health care costs.  Its main purpose was to provide health insurance.  That's good and important, in and of itself.

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Sherman Award deadline is this week

Reminder: Friday, March 28 is the deadline for submissions to the Sherman Award for Excellence in Patient Engagement.  Details here.

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Patients with complex needs on WIHI

Madge Kaplan writes:

The next WIHI broadcast — ​Bright Spots for Patients with Complex Needs — will take place on Thursday, March 27, from 2 to 3 PM ET, and I hope you'll tune in.

Our guests will include:

• John W. Whittington, MD, Lead Faculty, Triple Aim Initiative, Institute for Healthcare Improvement
• Crispin Kontz, Manager, Support and Clinical Systems, Alberta Health Services (Edmonton, Canada)
• Catherine Craig, MPA, MSW, Independent Consultant, Community Health Transformation, Care Coordination
• Ann Lindsay, MD, Co-Director, Stanford Coordinated Care, Stanford Hospitals and Clinics

When Atul Gawande wrote in The New Yorker about high utilizers of the health care system in Camden, New Jersey — “hot spotters,” he called them — he attached faces and stories to the very real human drama and challenge of meeting the needs of some of the most complex patients among us. Since that article was published in 2011, interventions and initiatives to better support, care for, and partner with populations with costly and life-draining multiple illnesses and problems have grown in number and effectiveness. We’re going to touch base with some of the people spearheading this work on the March 27 WIHI: Bright Spots for Patients with Complex Needs.

Dr. John Whittington and a team here at IHI have been working with close to 140 organizations around the world for several years now on transforming how health care and communities engage with people with complex needs. Dr. Whittington has been relentless in harvesting the learning from this work, and we’ll all benefit from that on the March 27 WIHI. He has often collaborated with Catherine Craig, who brings deep experience about raising the health and the expectations of especially disenfranchised communities. Crispin Kontz has some fresh results and progress to share with us from Alberta Health Services in Canada. And Dr. Ann Lindsay is going to tell us about a truly innovative new clinic she co-directs that’s been designed explicitly for individuals with chronic health problems and illnesses. Care coordination is its middle name. Imagine what we might learn from this model! Imagine, also, what can come from community coalitions, data sharing, co-designing with patients, greater use of community health workers, and more.

In the US, 5 percent of the population contributes to 50 percent of all health care costs. Most of us can recite this statistic as though it were immutable. But it need not be. Please listen in to the March 27 WIHI to hear from four outstanding experts about improving the health and the lives of complex populations.

I hope you'll join us! You can enroll for the broadcast here.

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Lean comes in small doses

The concept of Kaizen--small, incremental improvements--is at the heart of the Lean philosophy.  But small does not mean meaningless.  Each such change offers the chance to deliver better service to the customer and/or provide better working conditions for the staff.

Thus, when I see examples of Kaizen in action, I smile.  The changes are the result of concerted efforts by people on the front line, supported by their managers.  They represent a thoughtful approach to process improvement, one that goes beyond a simple project and reflects an underlying element of what it means to be a learning organization.

Here are two examples from Jeroen Bosch Ziekenhuis in the Netherlands.  You see below before and after pictures of the nurses work station in the dialysis unit.  The top picture shows a cluttered workspace that interferes with the everyday job of the nurses.

With some simple reorganization and the construction of some inexpensive shelves, items are placed in a manner that allows the work surface to be clean of obstructions.

The next example is elegant in its simplicity.  The walls of the clinic--including connections for electricity and other utilities--were suffering damage from the dialysis chairs when patients leaned back to be comfortable.  By affixing a line to the floor, each chair is assured of being "parked" correctly--far enough from the wall--eliminating the potential for expensive damage and disruption of work flows.

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The spread of Lean in Den Bosch

We're back in Den Bosch at Jeroen Bosch Ziekenhuis for the next phase of Lean training workshops for senior adminstrative and clinical leaders.  Our first session always includes the Toast Kaizen video, featuring GBMP's Bruce Hamilton.  It never fails to generate laughs from the crowd as Bruce fumbles his way through a series of process errors making toast for his wife. By presenting a simple, common task to the class, Bruce illustrates the types of wastes that occur in many product production and service delivery organizations.  It is easier for the students to then be aware of similar problems in their own work environment.

Then it was off for a period of shadowing front-line staff to see what life is really like for the people doing the work in the hospital.  Harriëtte, from the pharmacy, found herself observing the situation in the catheritization laboratory. But first she had to don appropriate headgear for the occasion.

Top level commitment to the training program was demonstrated by the participation of Peter Langenbach, a member of the executive board of the hospital, who serves as chief financial officer.  He, too, traded his suit coat for a white coat for the occasion as he shadowed a nurse and watched the process used to prepare medications for her patients.

Two separate groups of students met today and returned from the shadowing experience to describe and categorize the different kinds of waste they had viewed on the front line.  Their observations were typical of those that could occur at virtually any hospital.  They came to understand, too, that such waste does not exist because the staff is not well intentioned, thoughtful, and hard working.  Rather it comes to exist because the staff is well intentioned, thoughtful, and hard working. When front-line staff encounter obstacles to their tasks, they invent work-arounds so they can get the job done.  The problem, of course, is that work-arounds do not solve underlying systemic problems and, indeed, add to the complexity of the organization.  In the following workshop sessions this week, we'll explore how Lean principles can help in the design of counter-measures to offset these areas of waste.

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It could have happened to anybody

My rule of thumb is that when an error is made and you can say, "It could have happened to anybody," there is a systems problem behind the error.  Here's a story that demonstrates this so clearly, courtesy of our friends at MedStar Health.

As you watch the video, imagine the more common scenario in hospitals, where the clinician is blamed and where the underlying problem goes unsolved.

Thanks to Annie for sharing her story!

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Congestive Heart Disease Information

Congestive heart disease is a physical disorder in which the heart no longer pumps hard enough. Since the heart pumps weakly, blood can back up into the lungs, liver, gastrointestinal tract, and extremities.

Congestive heart disease is also called congestive heart failure (CHF), cardiac failure, or heart failure. These names can be misleading, since they seem to indicate that the heart has totally failed and that death is imminent. This is not the case. Congestive heart disease is nearly always a chronic, long-term condition, although it does sometimes develop suddenly.

How Common Is Congestive Heart Disease?

Of 100 people between the ages of 27 and 74, approximately 2 have congestive heart disease. That means about 6 million people in the U.S. are affected by the disease. After age 74, congestive heart disease becomes more common. It is said to be the leading cause of hospitalization among senior citizens.

Causes of Congestive Heart Disease

Congestive heart disease has many causes. They include, but are not limited to, the following causes:

* Weakening of the heart muscle due to viral infections. The weakness may also be caused by toxins such as alcohol abuse.

* Weakening of the heart muscle by coronary artery disease that has led to heart attacks.

* Weakening of the heart muscle by heart valve disease that involves large amounts of blood leakage.

* Heart muscle stiffness caused by a blocked heart valve.

* Uncontrolled high blood pressure, also called hypertension.

* High levels of the thyroid hormone.

* Excessive use of amphetamines ("speed").

Symptoms of Congestive Heart Disease

Either side of the heart muscle may weaken and cause congestive heart disease. The symptoms of congestive heart disease depend on the side of the heart that is affected. They can include these:

* asthma that can be attributed to the heart

* blood pooling in the body's overall circulation

* blood pooling in the liver's circulation

* enlargement of the heart

* shortness of breath

* skin color that appears bluish or dusky

* swelling of the body, especially the extremities

Congestive Heart Disease Risk Factors

As is true with most heart disease, family history is a major risk factor for congestive heart disease. Genetics cannot easily be altered. Age is a second risk factor that cannot be changed. Congestive heart disease is particularly prevalent among older people.

Aside from those two, however, risk factors can and should be addressed. Here are 7 risk factors for congestive heart disease that you may want to discuss with your health care provider.

1. High blood pressure: This is the highest risk factor for congestive heart disease! Men with uncontrolled high blood pressure are twice as likely as those with normal blood pressure to suffer congestive heart disease. If a woman has uncontrolled high blood pressure, she is three times as likely as women with normal blood pressure to develop congestive heart disease.

2. Heart Attacks: This is the second highest risk factor for congestive heart disease. Those who have had heart attacks that resulted in damage to the heart muscle, and scarring of the muscle tissue, have increased risks of experiencing congestive heart disease.

3. High Cholesterol: Showing high levels of cholesterol, particularly when levels of HDL are low, is listed as another risk factor for congestive heart disease.

4. Diabetes: Both type 1 and type 2 diabetes are risk factors for developing congestive heart disease.

5. Obesity: Men and women who are overweight unnecessarily increase their risks of experiencing congestive heart disease. The heart must work harder when the body is not at a healthy weight, and can begin to lose its ability to deliver blood efficiently.

6. Prolonged Physical Inactivity: A sedentary lifestyle, with little exercise, puts people at risk for congestive heart disease, especially as they increase in age. The heart needs cardiovascular exercise to remain strong and able to function well.

7. Smoking: Smoking increases the heart's workload. It also affects the lungs. This is a risk for congestive heart disease that anyone can eliminate.

CAUTION: Please see your doctor if you have reason to think you may have one or more of the risk factors or symptoms of congestive heart disease. The information contained in this article is for educational purposes only.

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Leadership doesn't have to be rocket science

My friend and colleague Leah Flynn Gallant has started a website called Engineering Leadership Development, with the subtitle "Because leadership doesn't have to be rocket science."

Leah helps run a number of leadership training programs for MIT students and has a lot of interesting observations on the subject.  Please take a look and give her some feedback!

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Health communications at Tufts this summer

I'm pleased to pass along this note from Professor Lisa Gualtieri, Tufts University School of Medicine, Department of Public Health and Community Medicine:

The Tufts University School of Medicine’s 2014 Summer Institute offers three courses critical to staying current with the field of health communication:  

·         Mobile Health Design a synchronous 5 week online course

·         Digital Strategies for Health Communication, a one week course delivered on our Health Sciences campus in Boston

·         Health Literacy Institute, a one week course and professional forum also delivered on our Health Sciences campus

For professionals seeking a more comprehensive experience, the Health Communication Program has just launched a new academic offering, the  Certificate in Digital Health Communication. This program provides the foundational principles of health communication through a digital lens.  Participants will learn how to create targeted health communication messaging and campaign development using digital media such as the web, social media, and mobile technologies.  Designed for working professionals, the certificate can be completed on a part-time basis in one year, from summer to summer.  The program starts with Digital Strategies for Health Communication in June and continues with two half credit courses in the fall, one full credit course in the spring and Mobile Health Design the following summer. 

Here are what past participants have said:

“Taking the Digital Strategies course greatly expanded my knowledge and proficiency for using technology and social media in clinical research. From a dissemination standpoint, it is essential to incorporate the effective use of technology to develop a communication strategy, maintain a web and mobile presence, and successfully communicate with the patients and the research community. Thanks to the tools I learned in Digital Strategies, I am now able to effectively use technology to accomplish these goals."
Laurel K Leslie, MD, MPH, Tufts Medical Center Floating Hospital for Children

“This was the best professional development course I’ve been to. The following week I wrote part of a proposal based on what I learned; my company won that bid and I now lead online strategy for the project”. 

Zena Itani, Senior Policy Associate, Altarum Institute, Washington, DC

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Help Alex go back to the craftsmanship of printing

Our buddy, Alex Green, the owner of a great independent book store in Waltham, MA, is asking for help with an Indiegogo project.  Please take a look!

He writes:

Helping an indie-bookshop owner step into the future by taking a step into the past...

Hello, my name is Alex Green.  I own a small, independent bookstore just outside of Boston.  For over five years, I've published authors the oldest way it can be done, using letterpress machines and lead letter type.  I've worked with Pulitzer Prize winners and even a Nobel Laureate, using this five hundred year old art to create beautiful prints of their works, but the catch is, I don't have my own equipment.  I could use your support to change that fact, purchase a press, and even open up to the public for classes!

Here's the video:

 

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Spear Webinar: Competing at Speed in a Fast-Moving World

Webinar–'Gap-Filling Organizations': Competing at Speed in a Fast-Moving World

 

MIT SDM Systems Thinking Webinar Series

Steven J. Spear, D.B.A., M.S., M.S.,

Senior Lecturer, Engineering Systems Division and Sloan School of Management, MIT

Date: March 24, 2014

Time: Noon – 1 p.m. EDT

Free and open to all

Register

 

About the Presentation

 

Determining, documenting, and addressing the gaps between an organization’s business requirements for products and services and the systems and capabilities available to achieve them is a challenge common to all industries. Many companies address this issue by deploying internal functions that reactively fill these gaps.

 

Although these efforts may differ by sector and context, those that are successful share several common characteristics in a systems-based approach that Dr. Steven J. Spear describes as the creation of "gap-filling organizations."
Spear will highlight some of the factors that make gap-filling organizations so useful:

• Speed—Responding faster and with shorter lead times than the larger anticipatory organizations that they support;
• Super-focus—Diving deep into specific problems to drive custom-tailored solutions; and
• Network multipliers—Maintaining a relatively small organizational core and involving subject matter experts as necessary.

A question and answer session will follow the presentation.

 

We invite you to join us!

 

Details/registration

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Next case: Just one doctor this time.

We've spent a lot of time recently focusing on how high-ranking people decided to let a private medical device company use the name and reputation of the University of Illinois in support of its product.

But there are smaller versions of this happening all the time.  These cases raise the same set of issues:  How can the public have trust that a doctor who has publicly endorsed a company or its products will use appropriate clinical judgment when caring for a patient?

I offer one recent example forwarded to me by a friend from Seattle, Washington.  On a Facebook post about the U of I, she asks:

How is this any different than my doctor having her endorsement on a medical equipment company's web site? 

Sure enough, we find the following endorsement:

Beyond that, we find that this same doctor participated in the product roll-out back in 2009:

"I use Smith & Nephew's hysteroscopic morcellator for all my polypectomy procedures, as do all of my colleagues," said Seine Chiang, M.D., Seattle, Wash. "The process of removing polyps has been greatly simplified with the TRUCLEAR System."

I have no reason to assume that Dr. Chiang is anything but a competent and caring doctor, but this kind of endorsement raises all kinds of questions.  Has she received financial support from this company, and, if so, has that been disclosed under the University's rules?  It is certainly not disclosed in these two examples.

Whether or not there was payment, she purports to represent the University of Washington in endorsing this product when she asserts that she and all of her colleagues use this equipment. The University's name is clearly set forth in this advertisement that is published and copyrighted by Smith and Nephew. Is Dr. Chaing authorized to represent her colleagues and the University?  If so, what approval process was followed to do so?

While not as egregious as the University of Illinois case, there are clear parallels.  Is anyone watching this at the University of Washington?  Is anyone watching this in similar cases throughout the country?

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Business, as usual

A story in HealthLeaders Media by Marianne Aiello asks "Can University of Illinois Hospital Save Its Brand?"

A decision by hospital leaders to participate in an advertising effort with an equipment vendor was intended to promote institutional expertise with robotic surgery. Instead it sparked an outcry among critics.

Despite the countless blog posts, tweets, and articles published about the University of Illinois Hospital & Health Sciences System's da Vinci advertisement controversy, I'm still left with one resounding question: How did so many high-ranking officials think featuring several physicians and staff in a medical device company-financed ad was a good idea? 

The question remains unanswered in a long-awaited report by the Vice President for Research. Charles Ornstein at ProPublica and Karisa King and Jodi Cohen at the Chicago Tribune summarize the report in their respective articles.

Ornstein writes:

Though the team acted “in good faith,” the review concluded, the episode pointed to the need for clearer rules and stronger enforcement.

“Based on discussions with individuals involved in the advertisement, neither the Office for University Relations, which works with the campuses to ensure consistent application of the University’s image and messages, nor the Ethics Office, was consulted regarding the participation of UIC employees in the advertisement,” said the report, which is dated March 15 but was released publicly yesterday. “Additionally, approval was not solicited from the Chief Operating Officer of the Medical Center as required by internal policy.”

Two doctors in the ad disclosed to the university in January, after the ad ran, that they had received “$5,000 or more aggregate income from and/or have greater than $5,000 investment or equity” in Intuitive. A third doctor reported a relationship with Intuitive but said it was valued at “none or less than $5,000.” All three had previously said they had no relationship with the company in 2013-14.
The review found that their disclosure forms were not signed by the head of the surgery department or other superiors, as required. (The head of surgery also appeared in the ad.)

King and Cohen write:

The Tribune, which first wrote about the ad last month, found some doctors did not initially disclose financial ties to the company as required by university rules.

Experts said the ad raised concerns for patients who rely on doctors to make unbiased recommendations about when to use the device instead of other forms of surgery. Though some physicians endorse drugs and medical devices from time to time, it is rare for an entire hospital to put its name behind a specific commercial product, experts said.

The report revealed several flaws with conflict of interest disclosure forms, including paperwork that is often incomplete or that includes incorrect information. It also found that university policies have been unclear about who should review an employee’s forms when that individual reports to multiple departments.

The hospital’s marketing staff, who coordinated the ad, also failed to consult with the Office of University Relations or the Ethics Office, nor did they ask for required approval from the Chief Operating Officer of the Medical Center, David Loffing.

But the most damning comment of the day in the Tribune story comes from a senior administrative official:

“If we had a do-over, we would do it right, or not at all,” Hardy said. “We needed a more fulsome discussion as to what we were going to do, and what policies would affect that and whether it was something worth doing.”

Whether it was something worth doing??

This is a public university, supported by taxpayer funds and devoted to offering patients unbiased and objective advice about medical treatments.  The advertisement and others like it have stretched the bounds of scientific analysis by asserting that there is substantive support for use of this technology compared to manual laparoscopic techniques.  Ornstein reports on just some of the controversy surrounding this modality:

Questions have been raised about the value of the da Vinci system.

A study found that deaths and injuries linked to surgery with the robots are going underreported to the U.S. Food and Drug Administration. And the American Congress of Obstetricians and Gynecologists said in a statement last year: “There is no good data proving that robotic hysterectomy is even as good as—let alone better—than existing, and far less costly, minimally invasive alternatives.”

But then he helps us understand the University's business commitment:

The University of Illinois has spent $4.6 million buying products from Intuitive over the past two and a half years, the review found. That includes $2.2 million for one of its surgical systems.

Ornstein could go further by mentioning the full cost of using these machines, in the form of disposables needed, and by mentioning the extra time required in the operating rooms to use them.

The University hawks this program in many forums.  For example, without comparing robotic surgery to manual laparoscopic surgery, its website says:

The University Of Illinois Hospital & Health Sciences System at Chicago has one of the country's most advanced centers for minimally invasive surgery. Robotic assisted surgery eliminates the need for large incisions that add to recovery time. Robotic assisted surgery allows the surgeon to view the surgical area in complete detail allowing them to work precisely while naturally moving the instruments.

Robotic surgery is a minimally invasive procedure for conditions that go beyond medication and non-surgical treatments. The robots are handled with the assistance of some of the world's most highly skilled surgeons. Since the surgeons are seated comfortably, with a perfect view of the surgical field, there is reduced risk of fatigue and greater accuracy compared with conventional surgery. With only a few small incisions and minimally scarring, robotic surgery offers quicker recovery time, reduced post- operative pain and reduced risk complications and infections.

The issue is not whether doctors received payment for the New York Times ad.  The issue is not whether doctors have received other payments from equipment manufacturer for  "educational" functions.

The issue is whether the University will allow its delivery of care to be so driven by financial concerns about its investment and marketing plan that it is blinded to the lack of scientific support for this modality.  The issue is whether patients being treated by the hospital are given proper and sufficient disclosure about the risks and benefits of this type of surgery compared to the alternatives.

The answer to the first question is clearly "Yes."  The answer to the second question is clearly "No."

The kind of corruption presented to us in this case is not so much a question of personal corruption.  It is a case of an organization so driven by its perceived business interests that it has lost touch with its underlying purpose and community service obligation.  It may also be a case of a senior administration that has allowed itself to be misled by self-serving clinicians whose view of appropriate standards of care may have been influenced by personal gain.  But ultimately, the fiduciary responsibility for meeting community standards of care lies with the Board of Trustees, and the view from here is that they are failing in that role.

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Leaders have a responsibility to set an example for others in their institution

I'm going to take advantage of the delay of the promised report containing "a methodical assessment of policies, guidelines, procedures and practices" concerning the University of Illinois ethics matters to send the University folks a helpful reference document.

Entitled "Conflict of Interest Policies for Academic Health System Leaders Who Work With Outside Corporations" this article in the Journal of the American Medical Association states:

New “Sunshine Act” requirements for disclosure by pharmaceutical and medical device companies of payments to faculty have led to increased conversation about conflict of interest (COI). Conflict of interest is defined as “circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest.” Conflict of interest is particularly relevant for those in the upper echelons of academic health system leadership—presidents, vice presidents, provosts, deans, chief executive officers, and the senior administrators who report to them.

A pertinent excerpt for the University to consider--as it thinks about a Dean of Medicine who serves on the board of a major pharmaceutical and medical device company--and as it thinks about the chief of a department and that Dean and a Vice President who recklessly used the name and reputation of the University in support of a private business--is the following:

Unlike most faculty and staff, senior institutional officials  are involved in financial and business decisions, including purchasing, resource allocation, and development of corporate partnerships, and have fiduciary responsibility to the entire institution.  In addition, it is critical that the public, students, employees, and faculty maintain confidence in the integrity of institutional leaders.  Leaders have a responsibility to set an example for others in their institution, especially for those training to be health care professionals. Independence and integrity of judgement are core precepts of professionalism.

Simultaneous service as an academic health system senior leader and as a board member for another organization with interests that overlap those of the academic health system creates a clear [conflict of interest.]

For these reasons, the fiduciary responsibilities of presidents, provosts, vice presidents, deans, chief executive officers, and those who report to them should preclude a paid relationship with an outside entity in related and relevant areas . . . .

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T + 3 and counting

The report to the President of the University of Illinois from the Vice President for Research was due on March 15.  That's three days ago.  Many are waiting.

The report is to supposed to evaluate the circumstances surrounding the use of the University's name and reputation in support of a private medical equipment supplier.  Recall that the VP was charged to "conduct a methodical assessment of policies, guidelines, procedures and practices, and where corrective changes are required we will take the appropriate action."

I guess he needed some extra time, but it's hard to understand why.  Maybe they'll explain that, too, when the report is issued.  Who knows: Maybe people are just distracted by the pending first round in the basketball tournament!

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The Courage Muscle. Free again.

These balloons always garnished Monique's house on St. Patrick's Day, when she and her family would invite friends and neighbors to celebrate the holiday.

In honor of the day, here's a repeat of a post from last year.  Michael and I just found a few dozen more copies of the book.  If you'd like one, free, just leave a comment with your full name and snail mail address.

When Monique Doyle Spencer wrote The Courage Muscle, A Chicken's Guide to Living with Breast Cancer, she couldn't find a publisher willing to take the book on.  It was funny, you see, and all the publishers thought it was inappropriate to have a funny book about cancer.  She showed me a draft, and I said that our hospital would publish the book, and we did.  Since then, it has brought good-humored hope and advice to patients and families around the world.  As one reviewer said:  "It should become a textbook for the medical professions and a guidebook for all who must confront, or support those who do, breast cancer. It is a beautiful book, beautifully written, that sweetly balances gravitas, zaniness and one person's truth. The author's humanity is in full, accessible display for all to see, share and learn from."

Monique died on Thanksgiving weekend in 2011, and along with our fond memories of her, the book remains.  I happen to have several dozen copies, as does her husband Michael.  We have decided to offer them at no cost to the readers of this blog.  First come, first served, until we run out.  Just submit a comment with your name and snail mail address, and we will send one off to you in a few days.

To whet your appetite, here is a story about Monique's humor.  It occurred a few months before in 2011.  Michael tells it:

Bobby McFerrin gave a marvelous concert, showing his voice as an instrument, to a packed house at Symphony Hall.  Afterwards he came to the front of the stage and sat, legs dangling, to answer questions. After a bit, Monique plunged in, without being acknowledged, and asked about whether he was asked to do "Don't Worry Be Happy."  I could feel the audience cringe.  McFerrin gracefully answered the question and said he does not perform the song and was sorry to disappoint.  Monique shot back, "I did not say I liked it."  The audience broke out laughing and McFerrin fell to the floor and lay down on the stage, doing the same.

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A new way to get spammed

Just what we needed, getting advertisements as text messages on our cell phones.  It's one thing for the cell company to try to sell you an enhanced service plan or something like that.  It's another to try to sell you a music album.

At least they don't charge you extra to be bothered.

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A fraud, but not a villain. What about us?

Bruce Ramshaw, a surgeon from Daytona, FL, has spent a lot of his career exploring the ramifications of complexity science.  In this article in General Surgery News, he offers some observations worthy of attention.

He starts with a story:

In September 2010, a 44-year-old academic superstar was named dean of the Tilburg School of Social and Behavioral Sciences faculty at Tilburg University in Tilburg, the Netherlands. Just one year earlier, this acclaimed social psychology researcher, Diederik Stapel, received the Career Trajectory Award from the Society of Experimental Social Psychology. Stapel moved to Tilburg University in 2006 and started TiBER, the Tilburg Institute for Behavioral Economics Research. By the pinnacle of his career, Stapel had authored and co-authored dozens of papers, some published in the most prominent journals, such as Science. The problem was that Diederik Stapel was a fraud. For more than a decade, Stapel made up data for his studies, regularly hoodwinking his co-authors, colleagues and students alike. Why would a recognized brilliant student and young researcher do this? He was clearly beyond capable of producing valuable scientific research. Why would he risk so much when he had the ability to do the work honestly?

The New York Times gave the answer:

In his early years of research—when he supposedly collected real experimental data—Stapel wrote papers laying out complicated and messy relationships between multiple variables. He soon realized that journal editors preferred simplicity. “They are actually telling you: ‘Leave out this stuff. Make it simpler.’” So, Stapel decided it would be better for his career to make the results of his studies simple to understand. He chose to make things up because that is what the editors, and presumably the journal readers, wanted to read. 

Bruce brings the lesson closer to home:

Although blatant fraud, as in the case of Diederik Stapel, does exist, it is not very common. A much more common problem in medical research is that the simplistic conclusions of published studies do not completely make sense when tested in the real world of patient care. Our traditional clinical research methods seek to prove or disprove a hypothesis to produce generalizable medical knowledge: that is, scientific medical truths that will apply to most (or to average) patients. Complexity science shows how incomplete this kind of thinking is when applied to the real (complex) world of patient care. Patients bring variability into the process and local variables make processes different in different clinical settings, even when the same disease is being treated with the same test or treatment.

We are a major part of the problem when we do not understand the complexity of the tests and treatments we prescribe and recommend. We need to evolve beyond our simplistic understanding of the results and application of medical research and apply a much more complete understanding of our world.

For essentially every test and treatment we have in health care, there are basically three subpopulations of patients who undergo a test or receive a treatment. First, there is a group that benefits from the test or treatment, but there is also a group that does not benefit (this is waste in our system), and finally, there is a group of people who are harmed by the test or treatment (directly or indirectly). Until now, our simplistic thinking has allowed us to rationalize that the waste and harm was just a necessary evil to help those patients who benefit from a test or treatment. Who could argue that a few unnecessary mammograms are justified to save a woman’s life? But complexity science argues, and the data from the use of vaccines and more than 30 years of screening mammography have shown, that it is not so simple and we are perpetrating a degree of waste and harm in patient care that is not sustainable and not ethical.

He concludes:

Diederik Stapel was a fraud, but he is not a villain. The villain in our world is not a person or an organization. The villain is our lack of understanding of complexity. Stapel’s desire to seek success by accommodating the desire to read simple results of complex biologic processes is the fault of no one individual but the fault of all of us who participate in the application of biological sciences.  

When we gain a more complete understanding of health care and our world, we will not only not allow simple-minded efforts like that of Diederik Stapel to achieve undeserved rewards, but we will also begin to address the waste and harm that is caused every day in our system that results from a much too simplistic understanding of how we care for patients and how we try to improve patient outcomes.

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Saskatchewan leaders take sides on Lean

I want to make clear that I am not taking sides in the internal political debates of another country, but I think it is instructive for all to watch a current scuffle in Saskatchewan.

Several years ago, the provincial government began an effort to adopt the Lean process improvement philosophy in the health care facilities across the province.  This was to require a large investment of time, money, and other resources.  Those of us in the health care world who have participated in Lean roll-outs--and have seen the value that it offers in increasing efficiency and quality--were impressed by the vision and commitment of the government.  We knew, as did they, that this kind of cultural transformation would take years, and we admired a government that had a long-term view of the return on the taxpayers' investment.

Over the months, consultants have been brought in to conduct training and offer support, and staff members in the various institutions have become more and more familiar with the philosophy and with the techniques and approaches used to create true front-line driven process improvement.

But the size of the investment has now raised concerns.  This article in the StarPhoenix summarizes the dueling points of view:

Under fire from the Opposition, Premier Brad Wall defended the provincial government's spending on the "lean" health quality management system.
 
"The overall amount is a significant investment and when we made the decision in cabinet, we're a government that looks at these things from the perspective of thrift and value and it was a long discussion."

The premier said the province is recouping its investment.

"We sought the very best and made the difficult decision to do this because of the dividends. What we're able to show is that between the savings just on the design of the children's hospital, on the design of the new Moose Jaw hospital, on the blood management system, we've recovered the entire costs of the four-year program, never mind all of the efficiencies that we have found," Wall said.

Opposition Leader Cam Broten took aim at the government over the issue during question period Thursday in Regina.

"There are good components to 'lean' . . . but this government has taken the 'lean' process and allowed it to become fat, allowed it to become a cash cow for consultants," Broten told reporters.

He said $40 million doesn't represent the total cost of "lean" in the province, since regional health authorities and other ministries also have "lean" contracts.

"I think it's gone overboard," Broten said. "I've looked at some of the Twitter feeds of health administrators who are paid to champion these kinds of things. It sounds like they're in a cult, the way that they pursue this type of language, over the top. We have to allow common sense to have its place."

This is an important debate with ramifications beyond this province.  I know from my visits and conversations elsewhere that people in health care throughout Canada are watching the Saskatchewan experience closely.  I think its fair to say that its success would be a signal throughout the country that it is possible to increase quality and safety and service levels and improve operating efficiency.

So how to resolve the political debate? I'm not taking sides, but it seems to me that this is too important an issue to have a "he-said-she-said" type of debate. Two ideas come to mind to help resolve the issue.  First, the government should be utterly transparent with regard to process improvement successes and failures during the roll-out.  Where successes have occurred, document what was achieved and how the stories of those advances are shared throughout the province and therefore contribute to the spread of good ideas.  Where failures have occurred, explain what has been learned from those experiments.

Second, bring in a (volunteer) group of outside experts to review the steps taken by the government and offer an objective appraisal of the roll-out.  Provide that report to the public and allow the government to explain how it will take those expert opinions into account going forward.

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Seeing America, the old way

Lee Crites has recently begun a nine month journey walking across America.  When his three daughters asked why, he gave ten reasons:

10. I want to go back to San Francisco and I'm tired of driving.
9. I need to lose 20 pounds.
8. There are millions of great people out there and I want to meet some of them where they live.
7. "A virtue to cover a multitude of sins" - Horace Kephart
6. My comfort zone has gotten too comfortable.
5. Walking is good medicine.
4. I have helped a lot of patients relearn how to walk in my physical therapist assisting role. Not all have been successful. I walk for those who cannot.
3. To remind my children that outrageous adventure can happen at any age.
2. I need to face my fears.
1. I want to form my own opinions of what America has become.

You can read his American Discovery Trail Journal here. 

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A plane crash every day

Every day that has passed as they search for the wreckage of the Malaysia Airline plane, another plane has crashed in America.  Well, better put, the equivalent number of people have died every day from preventable harm in America's hospitals.

Which story gets our attention?  Which is the greater public health hazard?

Remember Captain Sullenberger's words as he remarked on the scattered application of systemic approaches to safety in the health care industry: "We have islands of excellence in a sea of systemic failures. We need to teach all practitioners the science of safety."

"I wish we were less patient. We are choosing every day we go to work how many lives should be lost in this country."

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Inspiring

I missed this story a couple of years ago about a boy from Sierra Leone, although it was just recently reposted.  If you haven't seen it, I think you'll be inspired when you watch the video.

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Hypertension guidelines on WIHI

Madge Kaplan writes:

The next WIHI broadcast — How High? How Low? Shared Decision Making Amidst Shifting (Hypertension) Guidelines — will take place on Thursday, March 13, from 2 to 3 PM ET, and I hope you'll tune in. This is a special collaboration with the Journal of the American Medical Association that we're calling JAMA on WIHI: An Online Audio Forum on Quality.

Our guests will include:

• Craig W. Robbins, MD, MPH, Medical Director, Center for Clinical Information Services, Kaiser Permanente Care Management Institute
• Don Goldmann, MD, Chief Medical and Scientific Officer, Institute for Healthcare Improvement
• Peter Basch, MD, FACP, Medical Director, Ambulatory EHR and Health IT Policy, Medstar Health
• Eric Peterson, MD, MPH, Director, Duke Clinical Research Institute; Professor of Medicine, Division of Cardiology, Duke University Medical Center

Hypertension is a hot issue, especially in the US, where an expert committee recently recommended that the available evidence does not support initiating treatment (largely medication) for people 60 years or older until their blood pressure climbs to 150 over 90. The decades-long consensus had been to initiate treatment at 140 over 90, which is still the recommendation for adults younger than 60. The reasons for this change are possibly as complicated as the guideline process itself, but one of the chief concerns of the majority on the Eighth Joint National Committee (“JNC 8”) is the risk associated with aggressive treatment of hypertension in older adults.

So, can we talk about this? We certainly hope so, and we invite you to bring your real-world experience making sense of changing guidelines with your patients managing high blood pressure (and other conditions) to a special WIHI produced in collaboration with JAMA: March 13, 2014: How Low? How High? Shared Decision Making Amidst Shifting (Hypertension) Guidelines. 

Some experts take exception to the committee’s findings and the process itself. Our guests are going to take all that into consideration, but, with your help, we’ll focus primarily on the best ways to approach changing and often-debated guidelines when working with patients to achieve optimal health. (The new guidelines for determining who should be put on statins to lower cholesterol are another case in point.)

We want this discussion to be constructive and forward looking. And for that, we need your interest and participation. Thank you in advance for enrolling in the March 13 WIHI!

I hope you'll join us! You can enroll for the free broadcast here.

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