Coming back soon!

I've been on extended business trip and holiday to Asia.  Looking forward to rejoining all of you in a day or two.

The Wall

Memo to: @FIFAWorldCupTM @USYouthSoccer @MAYouthSoccer

As we proceed to this weekend's sporting events, we must take our lead from one of the world's finest equipos de fútbol (soccer teams).  Everyone knows that team members should stand side-by-side to protect the goal when there is a free kick, but these elite Under-4 players have taken the game to a new level.

On the last day of the season, coach Kris asked the girls to play goalie and this is what they came up with.  He reports that this presents an impossible defense for the coaches to score against.

There is already word from Brazil that teams preparing for the World Cup are watching the team's video replays for other tactical advantages. 

(Note to my loyal readers: I'm taking a solstice-inspired break from blogging for several days.  See you later!)

Two boats

Two years ago, I presented this picture of a boat and rowers from Jaffa, asserting some comparisons with both hospital management and state government involvement in health care.

A friend recently sent another take on this issue.  Here it is.  Perhaps it has a better chance of manuevering around the shoals of health care!

Testosterone: Fear-mongering by pharma and doctors

Here's the lede from a story in the Washington Post about prescribing testosterone to men:

In case you haven’t noticed, advertisements aimed at treating low levels of testosterone, or “low T,” have displaced those erectile dysfunction commercials with side-by-side bathtubs. The ads ask: Are you suffering from any of the following — depression, low energy, weight gain, fatigue, low sex drive?

If ever there were a case of medicalizing aging, this is it. Didn't we learn from the estrogen debacle? This is sheer predatory activity by pharma and doctors capitalizing on men's worst fear.

“Those symptoms are true of everybody as they age, to a greater or lesser extent,” says Glenn Braunstein, an endocrinologist and vice president of clinical innovation at Cedars-Sinai Medical Center in Los Angeles. Low T, he says, is the latest trend in direct-to-consumer advertising, promoting . . . products . . . that deliver the male sex hormone through the skin — a more convenient and less painful option than the injections that have been available for decades. 

These drugs, which require a prescription, treat hypogonadism, or low testosterone production. While doctors agree that testosterone therapy is beneficial in hypogonadal men, they are concerned about rejuvenation clinics and Internet sites that push testosterone — or supplements dubiously claimed to boost it — as a cure-all for aging symptoms. 

I'll offer this unscientific prediction: Fifteen years from now we will wonder why the incidence of prostate cancer is mysteriously increasing.

“For a drug, testosterone’s relatively safe,” John Morley [an endocrinologist at St. Louis University School of Medicine] says. “But no studies go longer than three years. What happens if you take it for 20 years?” If large numbers of men begin taking testosterone in their 40s to combat normal aging, he says, “are we going to see similar problems in aging populations that we saw in the Women’s Health Initiative with estrogen [replacement therapy,]” which turned up small but significant increases in cardiovascular and cancer risks? “Probably so.”

I hope but do not expect that men among my generation of baby boomers will pay attention to this advice from Dr. Braunstein:

“If you don’t need it, don’t take it,” he advises. “There’s absolutely no evidence that these treatments decrease aging. Ponce de Leon never found the fountain of youth, and the baby boomers won’t, either.” 

Please turn off all electronic devices

My Facebook friend Kris Williams reports:

Are you kidding - plane can't take off because there is a printer jam in the cockpit. We have been siting here for an eternity. Should I go tell the pilots I am in IT?

Tremayne Pickering replies: Is it a dot matrix?

A Jaime Williams says: Sounds like a scene from "Airplane."

Kris updates:

I have no idea. Now they are literally passing the paperwork from the ground staff to the pilots through a ladder and window.  We are sitting on the runway.  This is a total comedy.

Krista Reilly replies: I'm surprised the airline would share such a preposterous malfunction.

John McGlynn diagnoses the problem: Your electronic device is probably interfering with it.

Engaging hearts and minds on WIHI

June 27, 2013: An Engagement with Safety -
The Ground Game of the Partnership for Patients
(2:00 PM - 3:00 PM ET)

Featuring:
Ann Hendrich, RN, PhD, FAAN, Senior Vice President, Clinical Quality & Safety; CNO; Executive Director, Patient Safety Organization (PSO), Ascension Health
Deborah Morris Nadzam, PhD, RN, BB, FAAN, Project Director, JCR Partnership for Patients Hospital Engagement Network
Katherine Luther, RN, MPM, Vice President, Institute for Healthcare Improvement
Libby Hoy, Founder and Chief Executive Officer, Patient & Family Centered Care Partners (Long Beach, CA) 

When it comes to patient safety and reducing harm, one of the biggest challenges US hospitals face day-to-day is how to maintain a relentless focus on everything that needs to be improved and worked on, simultaneously. Building reliable systems, engaging leaders, insisting on a team-based culture, and ensuring that your staff has the necessary improvement skills have become essential underpinnings at every organization. So has joining up with something larger—to keep the pressure on, commit to stretch goals, and benefit from coaching and continuous learning.

The Partnership for Patients, launched by the US Centers for Medicare & Medicaid Services (CMS) in April 2011, is attempting to be that “something larger” for some 3,700 hospitals that have signed on to reduce nine hospital-acquired conditions by 40% and hospital readmissions by 20% by December 2013. What does this sprint look like from the vantage point of the 26 Hospital Engagement Networks (HENS) that form the backbone of the initiative? We’re going to check in with two of the HENS — Ascension Health and Joint Commission Resources, Inc. — on the June 27th WIHI: An Engagement with Safety - The Ground Game of the Partnership for Patients. Ann Hendrich and Deborah Nadzam will be our invaluable informants, along with Libby Hoy, who’s playing a crucial role embedding patient engagement into every hospital’s safety work. IHI’s Kathy Luther will also be on hand to share her perspective on what we’re learning about reducing harm from this ambitious initiative.

At one level, the Partnership for Patients is about doing all the right things to protect patients from a list of hospital-acquired conditions and avoidable readmissions. But as you’ll find out on the June 27th WIHI, if the improvements are going to be lasting, hearts and minds have to change, too. We hope you’ll join the discussion!

Please click here to enroll.

Minting money on the Tenet-Vanguard deal

Golly, I got things wrong when I suggested recently that the private equity firm that had been involved in Vanguard Health System didn't do as well as it might have.  My problem is that I just focused on the price received in the initial Vanguard IPO.

I should have been more alert to the comment I received: "Morgan Stanley and Blackstone (the private equity investors in Vanguard) made out much better than the public shareholders who bought in at the IPO (there's a shocker!), since they had a much lower basis and I think may have taken some of their money off the table pre-IPO through a dividend recap."

It turns out that my anonymous source was correct. Check out this report from Dealb%k. Excerpts:

The Blackstone Group’s sale of Vanguard Health Systems to a rival hospital chain, Tenet Healthcare, for more than $1.7 billion is the latest example of a successful cash-out. The leveraged buyout firm, led by Stephen A. Schwarzman, more than doubled its money on the deal.

Private equity firms have long contended that successful sales are what counts. On that measure, things are going well. Leon Black, the chief executive of Apollo Global Management, said this year that valuations were so favorable that Apollo was selling everything “not nailed down.” Big deals done at the height of the leveraged buyout boom are finding buyers.  

Vanguard’s sale is typical. In 2004, Blackstone injected just under $500 million of equity to acquire a majority stake in the hospital chain. The sponsor recouped essentially its entire investment via dividends. The sale announced on Monday mints another $650 million for Blackstone.

Well, what about the "normal" investors who might have purchased Vanguard stock during that IPO? As I noted, they have not done so well in the buyout compared to their alternative uses of money.  Well, as someone else commented: "Generally speaking, beware when buying shares in an IPO where the company has had private equity ownership."

Indeed.

Just one question.  How does any of this bring value to the patients served by the hospitals that are being passed around like chips during a Saturday night poker game?

Please be persistently dissatisfied

A tweet by @dripchamber caught my eye:

If I ever say, "Overall we're happy with the way the hospital is headed, infection-wise," please shoot me.

And the s/he links to this article in the Baltimore Brew.  An excerpt:

After one of the deadliest weekends in Baltimore in several years – 8 people dead, 20 shot in all during the period from Friday afternoon to Monday morning – comments by the city police spokesman are prompting blistering criticism in some quarters. 

“This is a little bit of a spike in terms of the weekend, but all in all, we’re pretty satisfied with the way the city is headed, violence-wise,” Guglielmi said, in Carrie Wells’ story in today’s Baltimore Sun. 

I loved@dripchamber's comment, not only for the clever directive that alludes to the violence covered in the article, but more importantly for what it stands for about quality improvement in hospitals.  Indeed, about quality improvement anywhere.

I have yet to meet any serious adherent to the concept of quality improvement who is ever satisfied with regard to progress made.  As my friend and colleague Roger Berkowitz, CEO of Legal Sea Foods, is wont to say about quality in his restaurants: "This is always a work in progress."  (Disclosure: I am on the LSF board.  Mainly because of Roger's commitment to quality.  But also because of the clam chowder!)

In the hospital world, whether people are engaged in Lean process improvement or another approach to the issue, the primary characteristic of those furthest along is modesty.  "We've learned a lot," they might say, "but mainly we've learned how far we have to go."

This implies a need for curiosity and experminentation and a leadership cadre that encourages blame-free learning at all levels in the organization.

As Virginia Mason's Sarah Patterson has said: "Just tell them to do it. Don't be afraid. It won't be perfect. Try it. Fail. Try it. Change. Keep going."

Cracking Health Costs: The book

Tom Emerick and Al Lewis have jointly provided a valuable public service for America's companies in a new book called Cracking Health Costs: How to Cut Your Company's Health Costs and Provide Employees Better Care.  (The offical release date is July 1, but you can order from Amazon at a pre-publication discount right now.) This is all really relevant as companies deal with the introduction of health exchanges and other chnages resulting from the national health care law.

The authors offer the following description:  "Cracking Health Costs reveals the best ways for companies and small businesses to fight back, right now, against rising health care costs. This book proposes multiple, practical steps that you can take to control costs and increase the effectiveness of the health benefit."

Remarkably, the book does as they say.  It casts asides fads, shibboleths, misconceptions, and just plain lies often offered by those many participants in the health care field who have collectively helped our country spend almost a fifth of our economy on a system that produces inferior results.  It reminds us that those participants view that level of national spending as success: After all, your costs are their income.

For example, it attacks the methodological flaws used by those who will try to convince you that prevention and wellness companies will save your company money.  It also splays out for you to see the roles of brokers and advisors, helping you to separate the wheat from the chaff in the advise and services they offer.

Beyond these broad areas of advice, it presents day-today suggestions you can use to help your employees.  These show up in helpful text boxes, like this one:

A Clip-and-Save List of Questions Your Employees Should Be Trained to Ask Their Doctors before Agreeing to Any Nonroutine Test (courtesy of our resident overtreatment expert, Brian Klepper, and the American College of Physicians) 

Do you have the results of my previous test? (if, indeed, you have had one). 
Will the test results change anything? 
What do you hope to learn from them? 
What is the probability and potential consequence of a false-positive result? 
Is there a potential danger if you don’t order this test? 
Does the test itself post any potential dangers or complications? 

Here's the table of contents:

Part One: Mostly Bad News
Myths and Facts about Your Health Benefit
Does Your Broker or Consultant Have Your Back? 
It’s Time for the Wellness Industry to Admit to Doping
This Is Your Health Benefit on Drugs
Your Employees’ Health Is Too Important to Be Left to the Doctors
Are New Delivery Models Déjà Vu All Over Again, Again? 

Part Two: Mostly Good News 
The Company-Sponsored Centers of Excellence Model Hospital Safety: How to Get Your Employees Back to Work in One Piece
Real Care Coordination: The Only Other Way to Save Money
Goofus Retains a Wellness Vendor, Gallant Implements Well-Being 

Part Three: What Should You Do Next? 
Health Insurance Exchanges: Should You Stay or Should You Go?

Oh, and did I mention that the book is funny and engaging? It is. You will have trouble putting it down.

The power of a second opinion

Here's a video that is worth watching.  It is about my friend Maria Bonyhay, who would likely be dead today if she had relied only on one doctor's opinion about her brain tumor.  (You may recall that I posted her story before, citing the Brain Tumor Foundation newsletter.)  I know things don't always change so dramatically with a second opinion, but it doesn't hurt to get another point of view.

Now here's one other thing. When I asked Maria's husband, Istvan (a neurologist), how they found Doctor Bruce, he said: "It is a long story, through multiple private connections. We hope that now it will be much easier for patients in similar situation to find Dr. Bruce, as he was who developed this surgical approach to remove tumors in the pineal region. Also, we hope that through Maria's example patients can make easier their best choice."

From Vanguard to Tenet

The big news today is that Tenet Healthcare Corporation is purchasing Vanguard Health System for $1.73 billion in cash ($21 per share), while also assuming $2.5 billion in the company's debt.  Vanguard's shareholders are lucky to walk away with this money.  It was just three years ago that Vanguard spent $1.5 billion to acquire Detroit Medical Center and just two years ago that the private equity firm was able to sneak by with an initial public offering at $18 per share.  Investors buying at that time will have made $3 per share, or about 17%, during a period (if I read the charts correctly) in which the New York Stock Exchange Health Care index rose about 30%.

So, let's see.  The private equity firm that owned Vanguard did worse than expected in its IPO.  Then, notwithstanding the lower base price, the public investors have also done worse than the market as a whole.

So much for a private equity strategy that hoped to make a bundle on purchasing hospitals to show top line revenue growth.  So much for a public investment strategy that thought it could achieve higher than expected earnings once the system had to operate in a normal financial fashion.

The press release accompanying the purchase suggests that the result will be accretive to earnings in the first year and that there will be annual synergies in the range of $100 to $200 million.  We'll see.

A story to make your hospital customer service folks feel better

@CapitalOne provides reassurance that hospitals don't always have the worst customer service! And it shows an ability, also, to fall behind on creating a learning environment. A friend writes:

You'll enjoy this customer service story. Remember I said Capital One's back office couldn't pull up my checking account even as the branch employee was looking right at it? It gets worse. I was there because they failed to give me my $100 bonus for opening a high-yield account with them and following their directions of writing 3 checks on it within 90 days, to qualify for the bonus. Neither the branch nor the back office understood the terms of their own promotion, but I had saved the brochure. The branch lady followed up and promised the back office would call me. They didn't.

She called today to find out they had not called me, then THEY called me just now and demanded that I fax them their own promotional brochure so they could see if I qualified!!

I was polite, and just said "Y'all are making me work awfully hard for this $100, especially when your own branch banker is telling you it's legitimate." She was undeterred. I have no landline so have to take it back to the branch to fax.

Honestly, is it worth the $100 to them to thoroughly piss off this customer? 

The sequel, a couple of days later:

Just to finish off the Cap One story, I went in there today to fax their stooopid promotion. Since the manager was free, I really gave him a piece of my mind, saying their inability to pull up my account and the absurdity of having to fax them their own promotion made me question their competence to do other transactions, and the shoddy customer treatment made me want to have nothing to do with them. I made clear my problem was not with his branch, but with corporate or whomever was treating me like a terrorist to be investigated rather than a customer. I didn't need the lousy $100 but it was not worth $100 to them to treat a customer like this, etc etc. And, as a parting shot, that the corporate rep wasn't even nice.

Just now I get a phone call, and it's the same rep. She has totally changed her tune, BUT she can't refrain from telling me they were able to get me the $100 by 'making an exception'.

GAAAAHHHH!! Still telling me I don't qualify, but they are doing me a favor!!

Since I'd had my rant for the day, I just said thank you and got off the phone as quickly as possible. Did corporate learn anything here? Absolutely nothing.

Cultural failure in the NHS and the CQC does not arise from the staff

I've been on airplanes a lot this weekend and therefore have had a chance to catch up on the international news that doesn't get covered in the US.  In particular, I'm trying to make sense of what's going on in the British health system.

First, I read in The i (a daily digest from The Independent):

Hospital inspections cannot be trusted, the head of the NHS watchdog admits.  David Prior, new chairman of the Care Quality Commission (CQC), made the stark admission after top officials at the health watchdog were revealed to have supressed a report highlighting failings at the Univeristy Hospital of Morecambe Bay NHS Trust.  More than 30 families are taking legal action against the hospital.

The Trust is being investigated by police over the deaths of eight mothers and babies.

Mr. Prior told his board: "We can have no confidence, I think, not just at Morecambe Bay but across many more hospitals, that we have done a proper job."  He also admitted to the BBC that the CQC was "not set up then, and we're not fully set up now, to investigate hospitals."

[Health Secretary Jeremy] Hunt told the Commons . . . "A culture in the NHS had been allowed to develop where defensiveness and secrecy were put ahead of patient safety and care."

The instant case includes the destruction of evidence, and The Daily Telegraph notes:

The NHS watchdog was last night accused of "broader and ongoing coverup" after refusing to name officials who ordered the destruction of evidence of its failure to prevent a maternity deaths scandal.

Jeremy Hunt . . . demanded that those responsible for the apparent cover-up ultimately be publicly identified, despite defending the CQC's decision not to name the individuals immediately.

The CQC claimed it could not disclose the identities of those who ordered the destruction of [the] report . . . due to data protection laws.

MPs derided the CQC excuse, saying it was in the public interest that individuals who destroyed evidenc be named.

Well, here we go again.  The body politic wants the blood of individuals, responding with an "off with their heads" approach. An editorial in the Telegraph jumps on this bandwagon, saying "Until individuals are held accountable for these appalling misdeeds, the culture will never change, however many structural reforms are undertaken."

While it is dangerous to judge from afar, I think this is the wrong focus, for it is clear that there are rampant systemic problems in the organization.  Look at this:

Dr. Heather Wood, who led the investigation which uncovered the Mid Staffordshire Hospital Trust scandal, in which up to 1,200 people died, accused the CQC of operating under a "culture of fear, which mimicked the very worst aspects of the NHS."

Such a culture does not arise over night.  While there might be short-term culpability among staff members, the people to blame are the senior leaders who have allowed their teams to develop practices and patterns of behavior that undermine the purposes and mission of the organization.

I recently wrote about a different kind of organizational failure, the highly publicized mistakes made by a division of the US Internal Revenue Service.  Referring back to an article I wrote in the Harvard Business Review, entitled "The Nut Island Effect," I explained one kind of dynamic that results in good teams going wrong. Whether the problems at the CQC parallel those of Nut Island or whether they reflect some other organizational failure, it is the senior leadership who should look in the mirror rather than asserting the exclusive guilt of others under their supervision.  Meanwhile, back at the NHS trusts themselves, questions still remain unanswered from their boards.

Labor-intensive care

How's this for hospital marketing? The strap-hanger handles in the airport train connnecting the terminals at KLIA, Malaysia. Look at all those people assiduously taking care of this one patient!

(Curious? More about the company, including medical tourism, here.)

Please help Elena record her cello concerto

I know a lot of my health care audience also cares about music and other arts, so I write with a request.  My friend, colleague, and neurologist Seward Rutkove writes in the hope of getting support of a Kickstarter campaign to recruit a new cello concerto for his talented wife, Elena Ruehr.  Here's the story:

Elena wrote the cello concerto called "Cloud Atlas" based on the book (not the movie); it was premiered in 2011 in San Jose, California with fantastic soloist Jennifer Kloetzel.  The Boston Modern Orchestra Project is now interested in recording it. BMOP is one of the most highly regarded orchestras in the world for recording new music, and this project will lead ultimately to a CD of Elena's complete orchestral works.  BMOP is committed to recording the piece, but needs funds to pay the 28 musicians who will perform it as well as the cost of the hall and the recording engineer.

To see more about the project visit this site and watch the 2-minute video:

http://www.kickstarter.com/projects/bmopsound/elena-ruehr-cloud-atlas

For more on Elena, check out her website:

www.elenaruehr.org

There are only three days to go, so please help out!

In memoriam: Edmund D. Pellegrino

Georgetown University photo in Washington Post

The Washington Post reports the death of Dr. Edmund D. Pellegrino, "a physician and former Catholic University president who was a leading figure in bioethics, a field of inquiry that has pushed doctors, patients and society at large to confront essential quandaries of caring for the sick."

Here are some excerpts, including some quotes that remain extremely pertinent:

Both physician and philosopher, Dr. Pellegrino was recognized as a founder of bioethics as a formal academic pursuit. The questions he explored, such as whether and when to let a patient die, had existed for millennia. But they became more urgently important as medical advances gave doctors ever greater power to extend and alter human life.

Medical ethics, he argued, matter as much in everyday bedside treatment as they do in dramatic ­choices involving organ donation or ventilators.

A doctor “binds himself to competence as a moral obligation” and “places the well-being of those he presumes to help above his own personal gain,” Dr. Pellegrino wrote, according to a 1986 profile in The Washington Post. “If these two considerations do not shape every medical act and every encounter with the patient, the profession becomes a lie: The physician is a fraud and his whole enterprise undiluted hypocrisy.”

His critics at times found Dr. Pellegrino’s views naive and out of touch with real-world economics. He was insistent.

“We keep talking about the cost of dialysis, which is $2.5 billion a year, but we spend that much a year on dogs at the track,” he told The Post in 1986. “We have to decide. . . . What kind of society do we want?”

“The capacity to make moral judgments, and to be self-critical, is part of being an educated person,” Dr. Pellegrino told The Post. “That’s what I do with ethics. I don’t set out to make trouble, but, when I do cause a stir, it’s only because I raise questions that strike me as unavoidable.”

Don Berwick could be governor

Don Berwick formally announced his candidacy for Governor of Massachusetts this past week.  As they are wont to do, the local press often first described him as a pediatrician and member of the faculty of Harvard Medical School.  While those things are true, most of the country knows Don as the former Administrator of the Centers for Medicare and Medicaid Services.  Those of us in the health care world, though, know him best as the author of the speech and booklet entitled Escape Fire, conceived and delivered when he was CEO of the Institute for Healthcare Improvement.

In this piece, Don masterfully weaves the story of the 1949 forest fire in Mann Gulch Montana with the experience of his wife's illness and danger-laden travels through the health care system.

Here's Don's narration, as related in an article by Dan Munro:

In 1949 a forest fire broke out in Mann Gulch Montana. Smokejumpers were parachuted in – a team of 15 headed by a foreman named Wag Dodge. The fire exploded – it was moving over 600 feet a minute – faster than most people can ever run and so 15 firefighters were trapped. Wag Dodge had an idea. He knew that they would lose the race back to the top of the ridge so he suddenly stopped. He lit a match and he lit a fire at his own feet. The fire spread around him. I imagine the other smokejumpers thought the guy was crazy. But his idea was this. If I burn the fuel around me – then when the fire comes and overtakes me – I’m safe – I’ll be in what came to be known as an escape fire. 

He tried to get the other smokejumpers to join him and nobody did. The fire overtook the crew killing 13 men and burning 3,200 acres. Wag Dodge survived nearly unharmed in his escape fire. It is just tragic to think of the answer being there but just in the moment not able to see it. That’s how embedded people come in the status quo. They can’t recognize an invention when it’s among them and they can’t give up their old habits. We’re in Mann Gulch. Healthcare is headed for really, really bad trouble. The answer is among us. Can we please stop and think and make sense of the situation and get our way out of it. It’s the same challenge.

As citizens of Massachusetts, we are indeed fortunate when a person of Don's caliber and his family put themselves forward into the belligerent arena of state politics.  Knowing him and his wife, I am sure they will enjoy the experience of learning the concerns, ideas, and suggestions of the thousands of people they will meet during the campaign.  Whatever the result of the election, we owe them a debt of gratitude.

Not like too many hospitals

#TPSER9 I write this after leaving the residents' and students' education programs in Telluride as I await the delayed departure of my Southwestern Airlines flight out of Denver airport.  It is delayed because there is a malfunctioning windshield wiper, and the mechanic (above) has been making repairs. We need to understand that this windshield wiper, on the co-pilot's side, is not likely to be needed while the plane is in flight as the airspeed cleans the windshield, or even on the ground taxiing, as it might not be raining. Nonetheless, quite appropriately, the flight will not commence--and passengers will not be loaded--until or unless it is fixed.

Let's contrast this with the procedures, or lack of procedures, followed in many hospitals.  How many times have surgeries begun without a proper time-out to ensure that all necessary supplies and equipment are at hand and in working order?  The lack of compliance with pre-surgical checklists is rampant throughout the world.  Sometimes this is from a lack of training.  Sometimes it is because an impatient surgeon starts a case in violation of the protocol, and his/her OR team is too intimidated to mention the issue.  (Remember this episode from the TV show ER? An associated story here.)

As I have said before:

Sometimes, I remind myself to be patient.  It is hard to change the medical system quickly.  But, more often,  I find myself agreeing with the words of Captain Sullenberger:

"I wish we were less patient. We are choosing every day we go to work how many lives should be lost in this country. We have islands of excellence in a sea of systemic failures. We need to teach all practitioners the science of safety."

I hope and trust that our attendees these last few days in Telluride will have the commitment and courage to make a difference during their careers.

An outcome review cannot pick and choose its findings -- or can it?

In the last two days, I have written two posts about articles in the Journal of Pediatric Surgery which, in my mind, raised ethical questions in the presentation of clinical data.  The topic was surgery undertaken to to repair a condition called pectus excavatum (sunken chest).  The major article contended that there had been an exceptionally positive record of this procedure, as measured by clinical studies.

Helen Haskell is the mother of Lewis Blackman, a boy who died from complications of the procedure on November 6, 2000.  When Helen read the March 2002 article, she wrote a thoughtful letter to the JPS.  Here, with her permission, are excerpts from her letter of May 13, 2002 to Jay Grosberg, MD, Editor in Chief:

You may imagine my surprise when I read the opening sentence in the results section of this article, "There were no deaths either after the MIRPE or the MRR." Lewis was a healthy child who died as a result of complications of the pain management regimen for the MIRPE procedure. Pain management has been a major problem for this procedure. While there were certainly standard of care issues involved in his death, that surely can be the case with any surgical complication, in any institution. This outcome can by no stretch of the imagination be considered irrelevant to a discussion of complications of this surgery.

The retrospective chart review in this study was structured so as to terminate four weeks before Lewis' surgery. While this may technically provide a rationale for failing to mention what can hardly be considered an inconsequential complication, it cannot help but raise questions about the intention of the authors, three of whom were intimately aware of Lewis' case. Furthermore, other serious complications that occurred at MUSC [Medical University of South Carolina] within the review period have also been omitted. . . . There is, however, no indication in the text that the list of complications in anything but complete. For those looking for information, such omissions are fundamentally misleading. An outcome review cannot pick and choose its findings.

The question is whether your intent is to allow your journal to function as a forum for competing advertisement or as a serious scientific publication. It is time for an open published debate, based on standardized and complete of data, on the pros and cons of the . . . procedure.

This is an elective procedure usually performed on healthy children, often for entirely cosmetic reasons.  You will search a long way before you find a parent who will knowingly vounteer his child for an experiment. Pediatric surgeons should be equally unwilling to volunteer their patients.

Helen received a reply from the editor saying the article had been "peer reviewed by three editorial consultants." He acknowledged that "the patients in the study . . . preceded the date of your son's experience," but "based on the information you have provided, the content of [the] manuscript would not be altered."

As noted by Rosemary Gibson and Janardan Prasad Singh in The Treatment Trap (page 122, with my emphasis):

The people on the front lines who lie down on the gurney are the forgotten ones.  The only shield they have is the wisdom to know the difference between solid evidence and commercial promotion. That wisdom may come from their own due diligence or a stroke of luck in finding good people whose sole purpose is their best interest.

The way I see it, the authors of this article and the editors of the JPS were not characterized by the last nine words in the previous sentence.

A medical journal's abdication of editorial responsibility -- Part 2

#TPSER9 I spoke too soon when I referred below to a 2001 article in the Journal of Pediatric Surgery where the editors decided to ignore the death of Lewis Blackman in a summary of cases concerning elective surgery to repair a condition called pectus excavatum (sunken chest).  A more extensive review was published by the same journal several months later in March, 2002 (Vol. 37, No. 3).  From the abstract:

Methods: From 1996 to 2000, 68 PE patients underwent MIRPE at one hospital, and 139 underwent MRR at another hospital. Ages ranged from 5 to 19 years (mean, 12) for MIRPE, and 3 to 51 years (mean, 17.3) for MRR. The mean pectus severity index was 4.2 for MIRPE and 4.9 for MRR (normal, 2.5). Results: There were no deaths after MIRPE or MRR.

One of the hospitals included in the survey was the one in which Lewis Blackman had his surgery and died. But the sample described in the article ended in September 2000, and Lewis died in November.

It would be virtually impossible for the authors of this paper--including surgeons from the hospital in South Carolina--and for the editors of the journal to be unaware of the Blackman case.  The ethical issues I raised in my first post are only compounded by this expanded article.

By the way, in 2005, the state of South Carolina passed a law named the “Lewis Blackman Hospital Patient Safety Act” to deal with the issues raised by this case.  As summarized here, it required all clinical staff in hospitals to wear identification tags, labeling job and status. The law also mandated that patients be informed of how they can contact an experienced doctor or summon help quickly when they experience medical problems in a hospital.