Tuesday, June 30, 2015

Who decides on non-profit status?

Here's a question for the lawyers out there.

A state court judge in New Jersey has determined that a local hospital is not really a non-profit and therefore should not have a property tax exemption.

Does the existence of a federal IRS ruling that the hospital is non-profit serve to insulate the hospital from a state judge's determination?  In other words, does the Constitutional supremacy clause hold in this kind of matter? Can the hospital win on appeal based on this logic?

In short, can the state find in one way for state jurisdictional taxes, based on its own logic, while the Feds find another way for federal jurisdictional taxes, based on theirs?

Monday, June 29, 2015

Trext helps patients and staff at the U.Mass clinic

Massachusetts and California are the hotbeds of healthcare-related start-ups, and I decided to join the board of one created by some recent college graduates.  It's called Trext and is designed to take advantage of smart texting, using decision tree logic to engage in interactive messaging with one person alone or with thousands of people simultaneously.  Especially it you are trying to reach a generation of customers who no longer read email, it is a powerful option.

Apologies if what follows sounds like an advertisement because . . . it is!  But I also thought my readers might be interested even if they are not potential customers.

There are lots of applications, but one that has been quite successful is in use at the U. Mass Amherst student medical clinic, Trext Virtual Wait.  The company explains:

Trext Virtual Wait is software that allows patients to send a text message to get a place in line at a walk-in clinic. It’s similar to the “take-a-number” system at a deli, but instead of a ticket, patients are assigned numbers over text message. When a patient is four numbers away, they are sent a reminder text telling them to come in. For patients who don’t text, they can be added to the line in person.

At the U. Mass walk-in clinic, 50% of patients were texting in and waiting remotely within six months.  The clinic spread the word with marketing posters such as the example above. However, mostly news of the service spread through word of mouth. 

The clinic has seen a 60% decrease in wait time in the clinic itself. This means students are able to go about their days (or stay in bed) without having to wait in the physical waiting room. A poll  found the patients more satisfied and they spread the word to their friends.

The peaks and troughs of traffic in the clinic have been smoothed, so providers aren’t as overwhelmed. The software has also been able to collect rich data to inform operations decisions.

Trext can also be used for messaging decision trees for health campaigns--for everybody from dentists to veterinarians--and a wide variety of other potential applications.

Did you expect otherwise?

In an example of a study that was not worth doing, John Commins at Healthleaders Media reports:

Only about 25% of internal medicine residents say they know where to find costs estimates for tests and treatments and that they can share those estimates with patients, according to a survey by the American College of Physicians.

The cross-sectional survey questioned more than 18,000 U.S. internal medicine residents who took the Internal Medicine In-Training Examination in October 2012. The study was published in the June issue of Academic Medicine: The Journal of the Association of American Medical Colleges.

"I was surprised that so few of the residents knew where to find costs of tests and treatments and that so few of them incorporated costs into any clinical decision-making," says study co-author Cynthia Smith, MD, ACP's Senior Physician Educator. "Patients are picking up more of those costs out of pocket and so they start to ask 'what are the relative costs?'"

Dr. Smith shouldn't be surprised.  Over two years ago, Massachusetts passed a law--the first in the country--requiring health care facilities to make prices available to consumers.  The effective date of the requirement was October 1, 2014.  The result?

The Pioneer Institute reports:

It's very difficult for Massachusetts consumers to get information on the price of medical procedures, according to a survey of 22 out of approximately 66 Massachusetts acute care hospitals and 10 free-standing clinics.

"Most Massachusetts hospitals don't seem to embrace a culture of price transparency," said Pioneer Senior Fellow in Health Care Barbara Anthony, who authored the report, "Massachusetts Hospitals Weak on Transparency" with assistance from Scott Haller. "Most hospitals barely comply with the minimum requirements of state law when it comes to making price information available to prospective patients."

Pioneer sought prices for one common procedure - an MRI of the left knee without contrast. While it was ultimately able to get the information from all 10 clinics and 21 of the 22 hospitals, the process was time consuming, confusing and replete with long rounds of telephone tag. Anthony concludes that "busy consumers will not have the time to doggedly pursue this information and instead will likely give up in disappointment and frustration."  

The time it took to obtain the information ranged from 10 minutes in rare instances to six or seven business days, with an average of two-to-four business days. Clinics were generally more forthcoming with price data than hospitals were. A 2012 state law that took effect in 2014 obligates hospitals, physicians, and clinics to provide prospective patients with prices for a medical procedure within two days. Insurance companies are required to provide the data online in real time. 

If hospitals haven't even been able to comply with the law, what chance do residents have in answering such questions? In fact, I'd doubt whether even the 25% figure is really accurate "on the ground."  Do you believe it when the study reports: 4,187 of 17,633 respondents (23.7%) agreed that they "share estimated costs of tests and treatments with patients"? (There would also be no way for the resident to know if such tests or treatments would actually be billed to the patients, as they cannot possibly be aware of the details of the patients' insurance plans.)

Empathy without action is empty

One of the most compelling videos in recent years is the one produced by the Cleveland Clinic entitled "Empathy: The Human Connection to Patient Care." Since its publication in February of 2013, it has been viewed by over 2 million people. If you don't shed a tear while watching it, I'd be surprised. It reflected very well on the image of the Clinic.

Less covered was the fact that before, during, and after this time, the Clinic was cited multiple times by CMS for flaws in patient safety oversight.  Joe Carlson at Modern Healthcare documented this in a story last June.

A three-month Modern Healthcare analysis of hundreds of pages of federal inspection reports reveals the 1,268-bed hospital spent 19 months on “termination track” with Medicare between 2010 and 2013 as a result of more than a dozen inspections and follow-up visits triggered by patient complaints. 

The Cleveland Clinic, with 36 deficiency complaints, ranked 20th on the list of hospitals with deficiencies stemming from patient complaints.  

How can these two aspects of the same hospital persist side by side?  I think we have to understand that there is often a corporate separation between the public affairs side of the house and the clinical governance side of the house in the hospital world.  The former takes money and creative thought.  The latter takes an unceasing commitment to clinical process improvement and especially to transparency.

This was noted by one of patients who complained, retired Air Force Col. David Antoon:

Hospital officials refused to show the inspectors all of the notes in Antoon's complaint file, and the doctor who claimed to have done the procedure declined to talk to surveyors about how the hospital handled the case, CMS inspection reports show.

Antoon, a commercial 747 pilot in civilian life until the operation left him incontinent, is baffled that medicine has no organization like the National Transportation Safety Board to address safety failures. “You cannot keep things concealed in aviation,” he said. But in healthcare, “They're just gathering data points from patient complaints. And every data point is a damaged life or a death.”

The power of transparency has been asserted and documented time after time.  Most recently, the National Patient Safety Foundation made the case that true transparency--between clinicians and patients; among clinicians within an organization; between organizations; and between organizations and the public--"will result in improved outcomes, fewer medical errors, more satisfied patients, and lowered costs of care."  The Children’s Hospitals’ Solutions for Patient Safety (SPS) Network, which originated in Ohio, is a clear example of these principles.

We also found this to be the case at my former hospital, where in 2008 our Board voted to be forthright about the number and types of cases that resulted in preventable harm to our patients.  At the time I noted:

We will be publicizing our progress towards these goals [of eliminating preventable harm] on our external website for the world to see. In other words, we will be holding ourselves accountable to the public for our actions and deeds. Our steps towards transparency have just been notched up a level.
We even used transparency to learn from one of the most egregious errors that can occur at a hospital, a wrong-side surgery

Years later, the importance of this approach--especially for the future leaders of the profession--was reaffirmed in a note I received from one of our residents (emphasis added): 

For me, a trainee at the time, the most important effect was that [transparency] underlined a shared sense of mission and purpose around quality improvement. The reporting didn't have a big direct effect on my practice--I just tried to learn how to put in central lines the right way, while my elders had already defined what the "right way" was. The indirect effect was as part of a sense of purpose, though.

The absence of a sense of purpose of this kind is toxic. For instance, if you have an advertising campaign that emphasizes our kindness or humanity, but we have no policies or practices that distinguish our kindness or goodness from anyone else's, it may be persuasive to our market as a branding tactic, but it's actively alienating to those of us who work within this system.

In short, empathy without action is empty. The resident concluded:

Conversely, if we walk the walk more than talk the talk, it's inspiring. Posting the data probably influenced very few patients one way or another--but it definitely made many of us feel like we were walking the walk. 

Sunday, June 28, 2015

Stand up for your rights

A friend writes:

Here's a story for you about small advances in funneling technology.

Hold the dicta, please, and give us news.

Dicta is a term used in the legal profession:

The part of a judicial opinion which is merely a judge's editorializing and does not directly address the specifics of the case at bar; extraneous material which is merely informative or explanatory.

I've noticed a tendency on the part of the New York Times to include more and more dicta in its news stories, adding editorial opinion--perhaps in the hope of making a story more interesting to readers--but clearly including content that in previous years would be more appropriately included in editorial pages.

The problem with such material is that it is included without documentation of sources.  The other problem is that it can be of questionable accuracy.  But, because it is contained in the New York Times, it can carry greater weight in the court of public opinion than might occur if it were in your weekly community newspaper.

The Times' recent coverage of the King v. Burwell decision offered such dicta--overstatements and unsupported conclusions.  Let me give you examples:

The law has also, by many accounts, contributed to a significant slowdown in the growth of national health spending and the cost of Medicare.

Use of words like "significant" is troubling and has no place in a news story.  We probably don't expect reporters to use the statistical definition, but we are left without a context for the standard they apply as to what "significant" means.  (One definition I found was "sufficiently great or important to be worthy of attention; noteworthy.")  You judge in this case.  Here's the abstract of an article from Health Affairs:

In 2013 US health care spending increased 3.6 percent to $2.9 trillion, or $9,255 per person. The share of gross domestic product devoted to health care spending has remained at 17.4 percent since 2009. Health care spending decelerated 0.5 percentage point in 2013, compared to 2012, as a result of slower growth in private health insurance and Medicare spending.

Is this "significant?" The Huffington Post offered more context:

The historic slowdown in the growth of health care spending since 2009 -- the lowest rate since the federal government began tracking the data in 1960 -- has sparked a debate about its causes. President Barack Obama partially credits elements of the Affordable Care Act, such as reduced fees for hospital services, for reduced inflation in national expenditures, but there's no consensus among experts. The actuaries at the Centers for Medicare and Medicaid Services are among those who believe the phenomenon is nothing more than a repeat of normal patterns that occur during and after economic recessions like the one that began in 2007.

Hmm, a "repeat of normal patterns." And let's look at the Medicare portion.  Is this about a slowdown in the growth of the cost of Medicare or the amount appropriated to fund Medicare?  Cost would be a reflection of the actual costs of disease treatment per capita. Appropriations are merely an administrative decision to not spend as much, such as results from rate changes or Congressional sequestration. Enrollment is based on demographic trends.  CMS notes:

Let's look further into the "impacts of the ACA" portion. A 2010 CMS report identifies the major Medicare savings that would accrue in the early years of the ACA.   They point to pricing and enforcement provisions--not changes in the structural delivery of care--and note that these are the ones projected to make the biggest difference over time, as well:

As for the items entitled "Improve the delivery of care" and "Reform the delivery system," the jury is still out.

Melanie Evans at Modern Healthcare summarized the situation in late 2014:

The CMS published for the first time the quality and financial performance for individual Pioneer accountable care organizations, a small, select group enlisted for Medicare's most ambitious test of the payment model. First year financial results show health spending slowed as much as 7% (PDF) among some ACOs and accelerated as much as 5% for others. In the second year, health spending slowed as much as 5.4% among those that reduced patients' medical bills and accelerated as much as 5.6% where costs escalated.

Eight of the nine ACOs to walk away from the Pioneer program in the first year reported an acceleration in health spending. Of those that dropped out, seven joined Medicare's less risky ACO option, the Shared Savings Program. But the Pioneer ACO that reported the sharpest acceleration in health spending, Plus North Texas ACO, dropped out entirely after costs grew 5.2% faster than projected. 

Indeed, the CMS ACO program had to be redesigned to postpone downside risk to hold onto hospital system participation.  The Times story does not reference what "many accounts" refers to, but from what I can garner, are the changes "significant?" I judge not.

Let's now proceed to another paragraph of dicta from the Times story: 

Industry executives said the law had fostered a revolution in the delivery of health care, encouraging hospitals large and small to increase the coordination of care and the use of electronic medical records while minimizing the readmission of patients who have been discharged. Doctors and hospitals have accepted that they will be rewarded or penalized for the quality of care they provide: their ability to keep people healthy. 

We could spend pages dissecting this collection of gross generalizations. A revolution? (Again, I found a definition: "A dramatic and wide-reaching change in the way something works or is organized or in people's ideas about it.")  That is hardly the case here.  Some incremental change in some places? Sure. Business as usual in most places? Likely. Talk to doctors and see if they have accepted that the metrics being applied to them and their hospitals truly reflect the quality of care or their ability to keep people healthy. Talk to procedural specialists and ask if the law has made a difference in their clinical judgments to engage in invasive procedures. Ask people what difference the use of EMRs has made in their practice.

The point is that the jury is out on so many of these issues. We don't need dicta in a news story. We need news.  The main proven attribute of the ACA is that more people have access to health insurance.  That's victory enough.

Saturday, June 27, 2015

Report on TOP 5

Back in November, I reported on an experimental program organized by the NSW Clinical Excellence Commission in Australia.  A summary:

The particular program I present here is called TOP 5.  It is lovely in its simplicity and low cost . . . and in the power of its results. It could be replicated anywhere there is a will. 

The idea is to come up with strategies to help caregivers who are responsible for dealing with people with dementia--and particularly the anxiety and agitation that can characterize this disease in the presence of certain environmental factors.  As described by the CEC, "TOP 5 is a simple process that encourages health professionals to engage with carers to gain non-clinical information to help personalise care. This information is then made available to every member of the care team, thus improving communication."

Well, now Karen Luxford and her colleagues have published a paper outlining some of the clinical outcomes of the experiment.  Among other things, they wanted to see if there was a documented reduction in falls and also in use of anti-psychotic drugs, but also they wanted to present more subjective measures about clinician and carer perceptions.  The abstract notes the findings:

Clinicians and carers reported high levels of acceptability and perceived benefits for patients. Clinicians rated confidence in caring for patients with dementia as being significantly higher after the introduction of TOP 5 than prior to TOP 5.

The benefits to clinicians included an increased satisfaction in their work and in their confidence in caring for patients with dementia. Overall, TOP 5 was acceptable to clinicians as a tool to enhance their work caring for patients.

Carer confidence in clinicians was increased when carers observed that clinicians used the strategies developed, indicating that TOP 5 assisting in the communication of this knowledge during clinical handover.

Both clinicians and carers reported that following TOP 5 implementation, the patients were less agitated and appeared more settled, providing indirect evidence for an improved patient experience of care. Staff used the TOP 5 tips to deal with agitation in hospitalized patients with dementia, reporting that this approach lessened the need for restraint.

A methodological difficulty was the absence of control groups in many facilities to measure changes in falls. Where it was possible to have a control group, this result was posted:

In the hospital where data from a control ward were available, random effects regression found a statistically significant decrease in all patient falls in the aged care ward using TOP 5, when compared over time with the control ward. Controlling for baseline differences, seasonal effects and existing falls prevention strategies, an average of 6.85 fewer falls per month occurred in the ward using TOP 5 (Ward A) compared with the control ward (Ward B) since the introduction of TOP 5. In the sensitivity analysis where falls were measured as a rate (falls/admissions), we also detected a relative decrease in falls in the ward using TOP 5, with the change in trend in the falls rate per month 23% lower in the ward using TOP 5 compared with the control ward since the introduction of TOP 5. However, this difference is only significant at a 10% level, not at the 5% level. 

On the drug issue, there were other tops of comparison problems, but this result was of interest:

Consistent data about pharmacy stock usage of non-regular anti-psychotics were only available for analysis from two participating hospitals during the TOP 5 implementation period and for the same time period of the previous year. One of these, a major metropolitan hospital, displayed a statistically significant reduction in the use of anti-psychotics following the introduction of TOP 5 with an overall reduction of 68% in average cost of anti-psychotics per month. At the second hospital, a principal referral hospital, there was no difference in overall expenditure or supply of most types of anti-psychotic; however, there was a decrease in the usage of Risperidone quicklets (a quickly dissolving oral medication) of 67 mg per month following the introduction of TOP 5 (P < 0.1). Both hospitals exhibited high-end usage of TOP 5 (average 14 and 24 per month, respectively). These decreases correlate with the findings that 61% of the clinicians surveyed perceived that there was less need for restraint (physical or chemical) for patients with a TOP 5.

Given these experiment design issues, the authors reach this conclusion--conservative yet satisfactory:

Our findings indicate that the use of a simple, low-cost communication strategy for patient care is associated with improvements in carer and clinician experience, with early indications of potential benefits for patient safety and potential cost savings to health services. Minimally, TOP 5 represents ‘good practice’ with a low risk of harm or unintended consequences. The TOP 5 strategy has potential for broader application by health services applying patient-focussed approaches to care delivery.

Indeed.  Worth pursing further and elsewhere.

Friday, June 26, 2015

So much for a paper-free society

A three-inch thick package arrived today in the mail.  It contained these documents from Blue Cross Blue Shield of MA to explain my Medicare Advantage plan:  Provider directory; pharmacy directory; formulary; and benefits summary. 

I fear that I will now get the same package once a year for the rest of my life, as the directories and such are updated.

Perhaps there is some provision in federal law that requires that such things be sent in paper form.  Or maybe BCBS of MA makes this decision on its own.

But, really, can't we get beyond this wasteful practice and just have these documents available on a website? Or, at least, give a subscriber the option to receive them electronically?

Addendum:  BCBS sent me a reply on Twitter:  "We share your frustration, mailings like this are required to be printed & sent. We'll continue to explore paperless as allowed."

Thanks, folks!

Thursday, June 25, 2015

Hey, UPMC. Don't forget to block the web sites, too!

Yes, in America.  Steve Twedt at the Post-Gazette reports:

Some UPMC hospitals are banning the Post-Gazette from sale in their gift shops, a move UPMC spokesman Paul Wood said was precipitated by “fairness issues” in the newspaper’s coverage of the health system.

At least three UPMC hospitals -- UPMC Shadyside, UPMC Mercy and Children’s Hospital of Pittsburgh of UPMC -- say they will no longer sell the newspaper.

Twice in recent years, UPMC executives have canceled the health giant’s advertising in the PG, citing dissatisfaction with the way UPMC was covered in the news pages and how it was portrayed in editorials and editorial cartoons.

''The Post-Gazette is edited without regard to any special interest, and our news columns are not for sale, at any price,'' said John Robinson Block, publisher of the newspaper. ''We have been here since 1786, and have as our purpose the same goal that UPMC was established for -- to serve the public's interest, not a narrow purpose.''

Post-Gazette Circulation Director Randy Waugaman said this week that PG delivery staff members were told by gift shop workers at UPMC Shadyside, UPMC Mercy and Children’s Hospital that they would not display the paper for sale.

“Our people tried to reason with them,'' Mr. Waugaman said, ''but the gift shop personnel said that they were ordered to do so by their superiors and it was out of their control.”

I wonder. Does UPMC also block the Post-Gazette internet sites on their server? I hear that works well in China and North Korea.

Are they crazy?

Computerworld reports on a test to see if robotic surgery can be conducted remotely--1200 miles away--checking to see if the lag time between the operators actions and the surgical incisions and other tasks would be too long.  Excerpt:

A Florida hospital has successfully tested lag time created by the Internet for a simulated robotic surgery in Ft. Worth, Texas, more than 1,200 miles away from the surgeon who was at the virtual controls. 

Next, the hospital plans to test lag times for remote robotic or "telesurgery" in Denver and then Loma Linda, Calif. 

"Based on these tests, we have determined that telesurgery is possible and generally safe for large areas within the United States," said Roger Smith, CTO at the Florida Hospital Nicholson Center in Celebration, Fla., where the tests were performed. "Limitations are no longer due to lag time but factors associated with reliability, social acceptance, insurance and legal liability. 

Let's put aside "reliability, social acceptance, insurance and legal liability."

Let's just think about what happens when, in the middle of laparoscopic surgery, a complication occurs and the surgery has to switch to "open" mode--and quickly.

Is this what the CTO means by "generally safe?"

Wednesday, June 24, 2015

We've been swindled

This is a true story.  It is not--repeat, not--about the quality of care received by my friend at two excellent Harvard teaching hospitals.  He was very clear to me that the doctors and nurses and other staff were attentive, considerate, communicative, and expert in their treatment of him.

Rather this is about a utter failure of our government to insist on interoperability between electronic health records, a failure made all the more outrageous in that the government has helped pay for those EHR systems in one of the biggest subsidy programs in modern healthcare history.

The friend was suffering from pain and went to the urgent care facility closest to his home, one operated by Beth Israel Deaconess Medical Center in one of the western suburbs of Boston.  The diagnosis was renal failure. A CT scan located the source of the problem, large kidney stones blocking the functioning of his kidneys. An ambulance was called, and the patient chose to go to the emergency department at Brigham and Women's Hospital, where his primary care doctor practices.

His creatinine level was over 8 mg/dL. (A normal level for men is  0.7 to 1.3.)

Upon arrival, he was whisked through the ED and was being prepped for surgery, but the doctors wanted to have a clearer sense of the location of the stones.  His kidneys were in no condition to have another CT with contrast, and so they wanted to look at the CT scan that had been taken just an hour earlier at the urgent care facility.

There was no way to electronically deliver the image to the BWH team.

The work-around? The BWH ED physician called his counterpart at the BIDMC ED, asked him to download the image from the BIDMC computer system and burn a copy onto a thumb drive, which was then carried three blocks away for hand delivery to the BWH team.

Fortunately, all went well for my friend.

Years ago, my friend and colleague John Halamka, CIO at BIDMC, told me that there was no technical reason that the BIDMC and BWH EHR systems could not be made interoperable.  But they still are not.

Indeed, this is a pattern nationwide, even though over 29 billion dollars of federal investment for EHRs were appropriated in 2009.  Whether you show up at an emergency room around the corner from your hospital or a thousand miles from your hospital, there is more likelihood than not that the receiving institution will not be able to gain access to your health record.  The term "meaningful use," the standard according to which the US government funds these systems, is laughably inadequate when it comes to interoperability.  We need to understand that a large number of healthcare systems, aided and abetted by some EHR providers, view it in their strategic interest to make it difficult for patients to move from one healthcare network (ACO) to another. 

We--the taxpayers and patients of America--have been swindled. Our national interest does not coincide with those corporate strategic interests.

And the fraud is likely to be compounded.  The next step in the process is a forthcoming Department of Defense procurement of an EHR system to serve the military and its dependents, whether being treated at military healthcare facilities or other facilities in the communities in and around our bases and other military installations. As I understand, there is no language in this multi-billion dollar procurement that would require the vendor chosen to achieve interoperability with those EHRs in community facilities where the government will send its patients--or where they might end up for emergent care.

Darius Tahir recently reported on Modern Healthcare:

A defense think tank says the government may regret its plan to lock the U.S. Defense Department into a 10-year contract with an electronic health-record vendor.

The Center for a New American Security released a report that sharply criticizes the department's procurement process for a new EHR system, which is expected to cost $11 billion over the life of the contract and has attracted fierce competition among four bidding teams.

“DOD is about to procure another major electronic (health-record) system that may not be able to stay current with—or even lead—the state-of-the-art, or work well with parallel systems in the public or private sector,” warn authors, who include retired Gen. H. Hugh Shelton and former Veterans Affairs Chief Technology Officer Peter Levin.

“We are concerned that a process that chooses a single commercial 'winner,' closed and proprietary, will inevitably lead to vendor lock and health-data isolation,” they conclude. 

We've been swindled once.  Will it happen again?

Loose talk

Is it just harmless joking . . . or a sign of underlying disrespect for a patient . . . or a symptom of a lack of professionalism. You be the judge in this story of comments recorded during a man's colonoscopy while he was under sedation.

(Thanks to KevinMD for the pick-up.)

And they tried defending this anesthesiologist in court on top of it. What a waste of money and time.

Tuesday, June 23, 2015

Ohio hospitals go to war against sepsis

The Ohio Hospital Association has declared war on sepsis, shooting for a 30% reduction in sepsis-related mortality. They note:

Sepsis incidence represents over 50,000 patients per year in Ohio or 5% of all discharges. Many of these patients continue to require additional healthcare services after surviving sepsis due to the complications of the disease. Early recognition and treatment can reduce the morbidity and mortality of sepsis.

The OHA Board identified and approved reducing sepsis in Ohio hospitals to be one of the key focus areas for OHA and Ohio hospitals for 2015-2016.  In 2014, OHA facilitated a successful rapid cycle improvement initiative for sepsis through the Leading Edge Advanced Practice Topics (LEAPT) program.  In 2015, we will be building on lessons learned during the LEAPT program. 

At a recent Quality Summit, James O’Brien, VP for quality and patient safety at OhioHealth, was the keynote speaker.  Jim is a founder and chairman of the board of the Sepsis Alliance.  The program also featured a panel discussion of representatives from Ohio hospitals currently engaged in actively reducing sepsis and monitoring improved compliance with bundles of care.

You can view the proceedings here. The video provides an excellent summary of the issues faced in early recognition and intervention for sepsis, and beyond. It is an excellent primer for those wanting to understand more about this disease state, but it is also a sophisticated presentation for those in the field.

Jim notes that sepsis is the most common reason for death in ICUs.  A patient arriving with sepsis has ten times more likelihood of dying than one who presents with STEMI, a form of heart attack that garners a lot more attention.  Nonetheless, he asserts, "We have a great opportunity to change the natural history of this disease--not over our lifetimes--but over the next five years."

Jim has a way of describing the disease that makes it approachable to laypeople like me. He explains, "We have an army at our disposal to fight infections.  What happens with sepsis is that your body starts attacking itself.  You suffer friendly fire as a result of the infection that has started."

The value in this kind of explanation is that part of the OHA effort is in spreading public awareness about this threat. It therefore has to be set forth in terms that are understandable to the media and the general public.

I'll leave you to watch the rest of the video to the extent you would find it useful.  I, for one, am very impressed with the OHA's commitment to this issue and also by the presentations Jim and the others offer to the people of Ohio and beyond.

Monday, June 22, 2015

Take that CPR course!

The folks at the NE Journal of Medicine report:

A new study asks if training in cardiopulmonary resuscitation (CPR) increases bystander CPR and survival. CPR performed before the arrival of emergency medical services is associated with an over twofold increase in 30-day survival after out-of-hospital cardiac arrest.


A second study used a mobile phone positioning system to dispatch CPR-trained lay volunteers, which led to a significant increase in bystander CPR rates.  

Want more?

Read the Insights post on the Now@NEJM blog.

Sunday, June 21, 2015

The danger of the ordinary and wrong

Thanks to Mike Davidge, at NHS Elect and NHS Wales, for sending along the link to an excellent talk by Gordon Caldwell, a consultant physician who works at Worthing Hospital in West Sussex.  It is essentially a primer on quality and safety improvement in hospitals and medical care in general.

Gordon actually made the video to practice a talk he was going to give a bit later, so it's not exactly a blazing cinematographic production.  It's simply a lovely exposition of key principles of process improvement.  He starts with three personal stories about patients and then draws lessons.

Somewhere about minute 11, this slide shows up, a concise definition of normalization of deviance, the tendency for the substandard to become the standard, a very important cognitive bias. (It is exemplified by the Columbia space shuttle disaster, left.)  This portion and the rest of the video present important lessons for us all.

Seeing through the future of radiology

I hope you'll permit me a small degree of self-satisfaction as I look back on the chiefs of service I recruited while CEO of Beth Israel Deaconess Medical Center. It is often in this domain (akin to Presidents appointing Supreme Court Justices) where a CEO can make a contribution that outlasts one's term of office.

One such individual is Jonathan Kruskal, the chief of radiology.  It was Jonny's demonstrated commitment to education and to patient safety and quality that elevated him to the top of the short list of some extraordinary people whose technical skills might have be comparable.  His arrival coincided with the current huge national effort to reduce the number of unnecessary diagnostic images that characterize American medicine.  That, as you can imagine, created a large number of stresses on a department that had previously invested heavily in equipment and staff to carry out more imaging than was sustainable.  He handled those business matters in a thoughtful and professional manner.

Now, Jonny and colleagues have published this article in RSNA Radiographics: " Metrics for Radiologists in the Era of Value-based Health Care Delivery."  It presents an excellent survey of the topic and gives food for thought for people in the radiology profession and to hospital and payer administrators as well.  The abstract follows:

Accelerated by the Patient Protection and Affordable Care Act of 2010, health care delivery in the United States is poised to move from a model that rewards the volume of services provided to one that rewards the value provided by such services. Radiology department operations are currently managed by an array of metrics that assess various departmental missions, but many of these metrics do not measure value. Regulators and other stakeholders also influence what metrics are used to assess medical imaging. Metrics such as the Physician Quality Reporting System are increasingly being linked to financial penalties. In addition, metrics assessing radiology’s contribution to cost or outcomes are currently lacking. In fact, radiology is widely viewed as a contributor to health care costs without an adequate understanding of its contribution to downstream cost savings or improvement in patient outcomes. The new value-based system of health care delivery and reimbursement will measure a provider’s contribution to reducing costs and improving patient outcomes with the intention of making reimbursement commensurate with adherence to these metrics. The authors describe existing metrics and their application to the practice of radiology, discuss the so-called value equation, and suggest possible metrics that will be useful for demonstrating the value of radiologists’ services to their patients.

Friday, June 19, 2015

Reprise: Fear, Forgiveness, and Father’s Day

As we approach Father's Day weekend, it is good to reflect on this blog post written by young doctor-to-be Caitlin Farrell last year ago during the Telluride Patient Safety Summer Camp:

Yesterday was Father’s Day, 2014. I woke up before everyone else in my room. Rolling out of bed, I padded down the stairs and brewed a cup of much-needed coffee. Pouring my face over the steaming cup, I looked out my window to the inspiring landscape of endless white-capped mountains. This year marks the ninth Father’s Day that I have spent without my dad, but the mountains and my purpose this week made me feel as though he were standing there with me, sharing our cup of morning coffee, just as we used to.

After taking the gondola ride into Telluride, the students and faculty plunged into our work of expanding our knowledge in the field of patient safety. We watched a documentary outlining the tragic case of Lewis Blackman, a 15-year-old boy who died due to medication error, miscommunication, and assumptions made by his medical team. The film explored the errors in Lewis’s care that have become far too common in our medical system: the lack of communication between providers and families, the establishment of “tribes” within medicine who do not collaborate or communicate with one another, the lack of mindfulness of the providers, and the culture in which all of these errors were permitted to happen.

But what resonated with me the most were the feelings described by Lewis’s mother. She defined her experience as one of isolation and desperation. “We were like an island”, she said. There was no one there to listen to her concerns. Ironically, Lewis died as a result of being in the hospital, the one place where he could not get the medical care that he so desperately needed.

A pain hit my stomach as she said these words. My family also shared the feelings of isolation, uncertainty, and loss throughout my father’s stay in the hospital. After Lewis’s death, his mother was not contacted. Instead, she was sent materials about grieving and loss in the mail. After an egregious error occurred during my father’s medical care, a physician did not give us an apology, but a white rose by a nurse.

An interesting discussion arose after the film. Our faculty emphasized the need for physicians to partner with the families of the patients. This will create not only a team during the course of treatment, but will cultivate compassion, empathy, and trust in the case of a terrible event. I know that despite the growing number of “apology laws” that protect, and even mandate, physicians to apologize to families after catastrophic events, few physicians actually do apologize. This results in families feeling like the events were there fault. I can say from experience that this is a burden that you can carry with you for years to come.

As I got back to my room and put down my books this conversation mulled in my mind. The death of my father has given me the fuel to pursue medicine and patient safety as my career. It has instilled in me passion, energy, and determination. Yet the one thing that I have not found in the nine years since my father’s death is forgiveness. Although I do not hold any one doctor or nurse responsible for the detrimental outcome in my father’s care, I have not been able to forgive the team for what happened. I have not been able to go back to that hospital. And as I sat on my beautiful bed in the mountains, I realized that I also harbored another feeling: fear. Fear of becoming a physician who does not practice mindfulness, who does not partner with my patients, who does not apologize for my mistakes. I am afraid that despite my best intentions, I will only continue the vicious cycle. A fear that I will allow my patients to feel as though they are “on an island”.

I put away my computer and got into bed. Lying awake, I took in the gravity of the day. I am so grateful to be here at Telluride among students and faculty who share my passion in patient safety. I could not have imagined a more perfect way to spend Father’s Day.

Thursday, June 18, 2015

What do Magnets draw?

Over three years ago, I wrote this piece on Magnet hospitals and took a lot of flak from people who said I was too harsh when I asserted that the Magnet organization was overstating things when it implied that Magnet hospitals had better clinical outcomes.  I noted:

Currently, there are 391 Magnet hospitals.  As I look through the list of those from my own state of Massachusetts, I don't see any that offer sufficient public, real-time data about clinical quality to prove the case of higher quality.  And given the dearth of transparency with regard to clinical outcomes nationwide, it is hard to believe that one could do so in any other state.

I did a Google search on the topic of "quality of care at Magnet hospitals" and found very little.  There was a 2010 thesis by Kelly Scott, a nursing student at the University of Kansas, entitled "Magnet Status: Implications for Quality of Patient Care," which said: 

In summary, this study did not find evidence to support the expectation that Magnet accreditation directly correlates to lower rates of hospital‐acquired infections. There was evidence to support existing research indicating that nursing workforce characteristics are better in Magnet hospitals. While Magnet accreditation remains the gold standard for nursing work environments, this status does not automatically lead to better patient outcomes.

So now look at this article by Jennifer Thew in HealthLeaders Media, which makes a similar point: 

A study in the June issue of Health Affairs supports the idea that the Magnet Recognition Program is, in fact, excellent at identifying excellence. But while researchers found the program to be an accurate tool in identifying high-performing hospitals, they also uncovered some surprising nuances about Magnet facilities' surgical outcomes—namely, Magnet recognition alone does not improve surgical patient outcomes.

"Many of us in the nursing community know that Magnet recognition confers a great deal of benefit to the staff nurses and the nursing leadership that are in those institutions," says Christopher R. Friese, PhD, RN, AOCN, FAAN, assistant professor at the University of Michigan School of Nursing in Ann Arbor.

But "there's been a question as to whether Magnet recognition was also associated with improved patient outcomes."

Friese says through the study, titled "Hospitals In 'Magnet' Program Show Better Patient Outcomes on Mortality Measures Compared to Non-'Magnet' Hospitals," he hoped to delve into how Magnet recognition was related to surgical patient outcomes.

For the published paper, he and his colleagues looked at 13 years-worth of national Medicare data for 1.9 million surgical patients hospitalized from 1998 to 2010 for coronary artery bypass graft surgery, colectomy, or lower extremity bypass. The anonymous data came from 1,000 hospitals across the country and the study was funded by the National Institute of Nursing Research.

According to the study findings, surgical patients treated in Magnet hospitals were "7.7% less likely to die within 30 days of their operation, and 8.6% less likely to die after a post-operative complication, compared with patients in non-Magnet hospitals."

"From the patient point of view, if I have to pick a place to go, I want to pick a Magnet," Friese says.

The Big But
"In this study… what we find is yes, Magnets are better," he says, "but Magnets were better to begin with. They were better many years before they were a Magnet and then during and after their Magnet recognition their [surgical] outcomes don't change."

In short, there is no doubt that Magnet status is good for many things, but let's not sell it as something it isn't.

"If the goal is to improve engagement, satisfaction, and staff retention, Magnet is a very well-established way to do that," Friese says. "If your motivation is, 'We have a problem with our patient outcomes [or] with our care delivery,' pursuing Magnet recognition… may not be the best use of your resources."

Wednesday, June 17, 2015

Beam Me Up, Scottie

Perhaps Janice Lynch Schuster has been reading too many of my posts about proton beam therapy.  She offers this haiku:

Beam Me Up, Scottie

Desperate patients
will try anything, better
or not, here they come.

Crew Resource Management in ICUs

Marck Haerkens and colleagues have published an important article: "Crew Resource Management in the Intensive Care Unit: a prospective 3-year cohort study." If you are trying to institute sustained clinical process improvement and/or high reliability in your hospital, it is worth a read.

The full text is available here, for free. Here's the introduction:

To err is human. As a result, everything that a human being devises, uses, or does is prone to error and failure. Human factors refer to environmental, organizational and job factors, and to human and individual characteristics which influence professional behavior in a way that affects performance and safety. Human factors account for the majority of adverse events in aviation. Human factors awareness training entitled ‘Crew Resource Management’ (CRM) was introduced in 1979 for aircrew after a series of accidents in which human factors were found to be the root cause. Following the implementation of CRM, a decrease in events led to CRM becoming the present day aviation operational standard.  Especially during time critical cockpit emergencies, CRM is considered vital for aircrew effectiveness, although sound scientific proof of CRM effectiveness in aviation is lacking.

In clinical medicine, human factor-related errors can have a major impact on patient safety. This is especially so in departments where high risk, time critical procedures on vulnerable patients are performed in a multidisciplinary team setting; human factors are likely to play an important role. Indeed, in critically ill patients, the occurrence of complications is related to outcome.

The defining aspect of CRM is a system approach to safety culture. Rather than focusing on individual failure, CRM aims to identify system flaws and uses standardized communication tools to improve process effectiveness and safety. The message of “good people are set up to fail in bad systems – let's figure out how to keep everyone safe” is more easily accepted than “you have a problem that needs to be corrected.”  This approach is fundamentally different from conventional quality and safety programs in medicine that focus on limiting variation in human behavior through regulations, or scenario-based team training, when these are not embedded in the more broad CRM approach. Contrary to aviation, there is currently no international standard for medical CRM training.

While the parallels between the critical processes in aviation and medicine suggest that a well-adapted medical CRM training may have potential to improve patient safety, evidence of the effects of CRM on patient outcome in a clinical setting is limited. Closed format intensive care units (ICUs) facilitate both CRM implementation and effect evaluation. The aim of this study was to assess the effects of CRM implementation on outcome in critically ill patients.

Excerpts from the abstract:

We performed a prospective 3-year cohort study in a 32-bed ICU, admitting 2500–3000 patients yearly. At the end of the baseline year, all personnel received CRM training, followed by 1 year of implementation. The third year was defined as the clinical effect year. All 7271 patients admitted to the ICU in the study period were included.

The primary outcome measure was ICU complication rate. Secondary outcome measures were ICU and hospital length of stay, and standardized mortality ratio.

Our data indicate an association between CRM implementation and reduction in serious complications and lower mortality in critically ill patients. 

Channeling Aristotle

As we consider the commercial success of high cost and clinically questionable proton beam machines, femtosecond lasers, and robotic surgery, we have come to suspect that these result in great measure from direct-to-consumer marketing by doctors during vulnerable periods of people's lives.  I recently learned of an article in Surgical Innovation that confirms these suspicions, but helps us understand the details a bit better. Oddly, the article also hearkens back to advice from Aristotle.

It's called "The impact of marketing language on patient preference for robot-assisted surgery."  Here's the abstract:

Robot-assisted surgery is gaining momentum as a new trend in minimally invasive surgery. With limited evidence supporting its use in place of the far less expensive conventional laparoscopic surgery, it has been suggested that marketing pressure is partly responsible for its widespread adoption.

The impact of phrases that promote the novelty of robot-assisted surgery on patient decision making has not been investigated. We conducted a discrete choice experiment to elicit preference of partial colectomy technique for a hypothetical diagnosis of colon cancer. A convenience sample of 38 participants in an ambulatory general surgery clinic consented to participate. Each participant made 2 treatment decisions between robot-assisted surgery and conventional laparoscopic surgery, with robot-assisted surgery described as "innovative" and "state-of-the-art" in one of the decisions (marketing frame), and by a disclosure of the uncertainty of available evidence in the other (evidence-based frame).

The magnitude of the framing effect was large with 12 of 38 subjects (31.6%, P = .005) selecting robot-assisted surgery in the marketing frame and not the evidence-based frame. This is the first study to our knowledge to demonstrate that words that highlight novelty have an important influence on patient preference for robot-assisted surgery and that use of more neutral language can mitigate this effect. 

It was Aristotle who long ago posited that persuasion is accomplished only in part by logical arguments (logos). Part of a persusaive appeal is relies on ethos, the trustworthiness and credibility of the person making the argument. In this case, that person would be the respected physician.  Another element of persuasion is pathos, an appeal to the audience's sympathies or imagination, often accomplished by a story that creates an emotional connection between the presenter and the listener.  Here, that story is delivered by a salesperson in terms of quality of life, drawing on anecdotes (not scientific findings) about patients who have been treated successfully.

As noted in this presentation from a college course (at Durham Technical Community College):

We can look at texts ranging from classic essays to contemporary advertisements to see how pathos, emotional appeals, are used to persuade. Language choice affects the audience's emotional response, and emotional appeal can effectively be used to enhance an argument. 

Thanks to authors Dixon, Grant, Urbach for confirming Aristotle's wisdom in the case of these new medical technologies.

Tuesday, June 16, 2015

Should it take a law?

The Telegraph reports on these comments by Sir Robert Francis about the NHS:

“I have learned from my son, and from other trainees, that we can learn a lot from the fresh eyes and idealism that doctors and nurses have when they start out. It is so important to exploit that, and not to crush it.” 

Sir Robert believes that many of the worst failings in the NHS occur when clinical staff become powerless — are left “shrugging their shoulders” rather than challenging poor care. 

He was encouraged, he says, by changes introduced by the Government to improve openness and transparency, including an overhaul of NHS regulation, ratings for hospitals and improvements to training of staff. 

But he feels more should be done. 

In particular, the leading QC wanted changes in the law to put the onus on staff to speak out if patient care is at risk – specifically a legal duty of candour to be placed on health professionals. 

“We do need to protect individuals by making sure they feel safe to report things to their employers,” he says. “I felt a statutory duty would have assisted that — too often those who raise concerns about things that go wrong become unpopular with colleagues and they need some form of protection.” 

I am not one to challenge Sir Robert's judgment on such matters, but what a shame that it should take a statutory solution to derive the result he seeks.  Around the world, there a few hospitals in which there is an environment within which such call-outs are encouraged.  These are the leading institutions in quality, safety, process improvement, and transparency.  They required no statutory approval to become learning organizations, in which all staff--regardless of rank or position--are encouraged and empowered to speak out when the situation arises.

Admittely, the majority of hospitals fall into the other category.  How many patients have been preventably harmed in those institutions? I suppose it is for the employees of those for which Sir Robert seeks regulatory protection, but what a tragedy--in the deepest sense of the word--that it should be necessary. 

Sunday, June 14, 2015

Protecting the public trust--a robotically assisted liver donation case

One common theme of the Lewis Blackman and Michael Skolnik stories is that of a surgeon who neglects to engage in a proper informed consent with a patient about the relative risks and benefits of a new surgical procedure. That both cases end in tragedy is immensely sad, but it would be a mistake to view the cases as isolated examples.  Indeed, they are representative of a broader violation of the public trust.  As I have noted with regard to the Blackman case:

[These are] cases in which an ambitious surgeon with a new technique or using new equipment takes on a case without providing full disclosure to the patient or family about the potential for increased risk compared to proven methods.  Some hospitals are complicit in promoting such "experiments" by not requiring IRB approval (i.e., human subjects review) or approval by some peer ethics committee.  They (surgeon and hospital) do this for business reasons, to offer themselves in a competitive marketplace as having "the latest and the best."  The surgeon then writes an article proclaiming the success of the new procedure, but that article seldom or ever looks at the long-term consequences, and it never indicates why--in terms of risk to the patient--the new procedure went forth in the first place.

Today, I summarize another case that, to me, raises similar concerns.  I offer it so that you can make your own judgment, and I welcome your comments below.

The surgery occurred several years ago.  Of course, I have no access to the detailed patient records.  I only have materials that are in the public domain, but they offer a story worth telling.

There is perhaps no procedure more compelling than a living related liver donation, and I count the surgeons who carry out these procedures as nothing short of heroic.  USCF notes:

In living donor liver transplantation, a piece of liver is removed from a living donor and transplanted into a recipient. The procedure, performed after the diseased liver has been removed, is possible because the liver regenerates or grows. The liver's unique ability to regenerate itself — combined with technological advances — allows more people to be donors.

Regeneration happens over a short period, possibly days to weeks and certainly within eight weeks. When surgeons remove a piece of the donor's liver, the part that remains grows back quickly to its original size.

That simple description belies the complexity and risks of this procedure, not only for the recipient, but also for the donor.  Back in 2010, Dr. William F. Balistreri, Medical Director, Liver Transplantation Program, Cincinnati Children's Hospital Medical Center, noted (cites omitted):

Live donor liver transplantation, specifically, performance of a major hepatectomy on a healthy individual who has no medical indication other than offering an allograft liver for the recipient, has long been viewed with caution and skepticism. Therefore, substantial efforts are expended to ensure the safety and long-term well being of the donor. The best outcomes for both donors and recipients have been maximized via technical refinements, innovative pre- and postoperative management strategies, and careful follow-up.

The estimated risk of mortality is 0.5 to 1%. Overall donor morbidity is high, estimated to be roughly 35%. This is usually related to the surgical incision and the possibility of blood clots; other reported problems include bleeding, infection, bile leaks, damage to the bile tree, or risks from anesthesia. Donors have reported chronic problems, including bile strictures, reoperations, and chronic pain.

In summary, the risk of dying from living liver donor surgery may be as high as 0.5% when donating the right lobe. If all complications are included, 1 of every 3 donors will experience a complication; most are considered minor or have no permanent sequelae. Thus, centers must carefully weigh the risks against the benefits. Likewise, potential living liver donors should balance the decision to donate with the advice of family, friends, an independent donor advocate, and the medical/surgical team. As stated by Marsh and colleagues, "no matter how carefully right lobar living donor transplantation is applied, the historical verdict on the ethics of this procedure may be harsh." 

Dr. Balisteri's remarks relate to the general case. Adding the use of robotic surgery techniques increases that risk, as noted in the textbook Transplantation of the Liver, by Ronald W. Busuttil, Goran B. Klintmalm (page 734):

So, now let's go back to 2008.  What more compelling story can we imagine than a brother donating a portion of his liver to his sibling?  Titled "True Example of Brotherly Love," Channel 13 reported:

Finding the perfect match means accepting that the right person may never come along. But for one Rockford area family the right donor is not only a perfect match, but a testament of brotherly love. The two underwent a first in the medical world. It's called the da Vinci Robotic Surgical System and now the University of Illinois Medical Center in Chicago completed the world's first minimally invasive liver resection.

This is basically bonding two brothers in a very unique way. Gary Tongue needed a living donor. Gary tells 13 News, "One day he showed up and wanted to know about the live donor transplant thing." "He" is Charles Tongue, Gary Tongue's half-brother. Gary had liver cancer which to him was a death sentence until both families started exploring. Charles says, "You have to be pretty much a perfect match. Weight, height, everything has to be about right."

With the most important match being blood-type. Dr. Enrico Benedetti completed the procedure by taking 60% of Charles' liver to replace the diseased liver in Gary. Doctors ended up finding five tumors saying it was worse then they thought. Gary states, "It was rough for awhile. It's one heck of a surgery to go through, but I think it's all going to worth it." Both came home last week and continue to recover together. Charles states, "It's a big weight off his shoulders that you know he's got it and things are working good and I know he's going to live now."

Gary continues on by saying "You really have to love someone to do what he did. By giving me a piece of that. It saved my life is what he did."

The publicity continued on a liver failure support group site, with the following headlines:

Surgeons used the Da Vinci System to perform the first ever robotic liver transplant, done at the UIC Medical Center.

Team performs world's first robotic liver transplant 

The story continues (emphasis not added):

Transplant surgeons performed the world's first minimally-invasive liver resection for living-donor transplantation last week at the University of Illinois Medical Center.

Gary Tongue, a Rockford area man, was the first to receive this transplantation performed by robotic surgical techniques. Charles Tongue, his half-brother, was the donor of the liver. When Charles realized how high his half-brother's risks were, Gary decided he could donate a portion of his liver to him and potentially save his life.

UIC's chief of general surgery, Dr. Pier Cristoforo Giulianotti and his colleague Dr. Fabio Sbrana, used the da Vinci Robotic Surgical System to remove 60 percent of Charles Tongue's liver. Surgeons then placed Charles' liver into his half-brother, Gary. The process would have included a long incision covering the entire upper abdomen that is required to remove the right lobe of the liver. UIC's surgical team, aided by the da Vinci Robotic System, used a different approach. They completed the procedure through four small incisions. They then removed the lobe through a three-inch incision in the lower abdomen to minimize any postoperative pain that patients might experience.

According to Giulianotti, "this transplant could be a turning point event heralding a new era in living-donor liver transplantation. The possibility of offering the donor a perfect minimally-invasive operation, increasing the accuracy of the resection while minimizing operative risk and blood loss, is a major step forward." 

Benedetti further explained transplantations by clarifying the risks involved. "We discuss openly the risk of the donor procedure with prospective donors and we routinely involve an ethical committee representative to ensure that the potential donor has fully understood the risks," said Benedetti. "We quote a risk of mortality of 0.2-0.5 percent, according to the current Literature data. We also quote a risk of about 30 percent of complications, including potential for bleeding, leak of bile, infection etc. Usually after resection the liver will regenerate to full size within five to seven weeks."

"Living donor liver transplantation is a life-saving option, especially for a patient with liver cancer," Benedetti said, "but it's very important that the donor understands the risks and be healthy enough to be a good candidate." He pointed out that in order to do this surgery doctors must operate on a healthy man to remove much of his liver. In the Tongues' case, Charles didn't hesitate to offer his liver to his half-brother, Gary. "I couldn't ask Charles to do this, but he insisted," said Gary. 

The same story showed up on this investor website.

In 2011, the case was summarized by the surgeons and others in an article in Transplant International.  Of relevance to us here, the article stated:

The possibility of using minimally invasive robotic technique for RLDH was discussed during the process of informed consent. All technical aspects and safety issues were explained, emphasizing the fact that the robotic approach had never been used before for RLDH. Subsequently, the ethics committee of the hospital evaluated the donor in accordance with the previously published standard protocol [6]. The donor agreed to proceed with the planned RLDH using robotic technique.

The "previously published standard protocol" is dated 2005. Its focus is on the general ethical standards that apply to liver transplants, well before any application of robotic surgery to this kind of procedure.  And we are left with no information as to how the surgeon explained the risk of the robotic technique to the patient, or how the surgeon explained why use of the robotic technique would be superior to standard procedures.

Of particular note, the authors acknoweldge that "the length of surgery was longer than that normally required for open right donor hepatectomy," but then state that "it must be considered that the complicated venous anatomy prolonged the total operating time."

I can't evaluate the latter clause, but my understanding from experts in the field is that the 8-hour duration of this case was considerably longer than a standard open donor hepatectomy, which is usually 5 to 6 hours.

Years later, the April 2015 Annals of Surgery "Recommendations for Laparoscopic Liver Resection" (Volume 261, Number 4, at page 623) notes that the quality of evidence--which presumably includes the above article--that the outcomes of robotic liver resections "are superior or not inferior to other techniques" is "low" and that the procedure should still be considered in the stage of development that requires institutional ethical approval and detailed reporting of results and maintenance of a registry:

It is hard to go back to 2008 and imagine what was in the mind of the surgical team for this case.  The issue is complicated by the intense desire of this hospital to be known as a center for robotically assisted surgery and the surgical team's long-term relationship with the company manufacturing this equipment.  (Interpretations today are also complicated by their financial relationships with the company.)

In my mind, the team should have been required to get IRB approval (a standard for objective review of human subjects experiments) for this case.  It was a new technology being applied to a live donor who had little to gain and well documented risks of morbidity and mortality.  Approval of the usual ethics committee for live donors was likely inadequate when adding on the unknown risk of robotic surgery.  The biggest risk of doing these cases in a minimally invasive way is that if you get into serious (and often sudden) massive bleeding you won't be able to open and control the bleeding quickly enough. The patient could die or have severe hemorrhage before it is controlled. There is also the additional risk of a longer time under anaesthesia.  An IRB review by uninvolved individuals with a variety of backgrounds would have balanced those potential risks against the additional scientific and clinical knowledge that could result from the experiment.

In summary, new surgical approaches like this--where there will not likely be randomized trials but where the risk is high--suggest that IRB approval should be part of the development of the new technology.  Absent that, the patient is held hostage to the possibility that the surgeon's personal judgment--no matter how well intentioned--might be colored by commercial strategies of that doctor, the hospital, and the equipment supplier.

Saturday, June 13, 2015

The practice of medicine is an emotional teeter-totter

Simulation games are a big part of the Telluride Patient Safety Summer Camp.  They are emotionally engaging, often high pressure situations, that mimic what can occur in clinical settings.  The lessons in teamwork and communication are embedded and lasting.  One such game is a teeter-totter--a plank on a cinder block--on which 7 people have to step up, one at a time, and hold the plank in balance--with the risk of getting off balance and "killing" an egg placed under each end of the board. (See here for a full description and explanatory pictures from a previous year.)

Here are some expressions of the residents participating in the game this week.