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Category: The Vault

Focusing on High-Impact Comparative Studies: Cardiovascular Disease in the Spotlight

Fifty years ago, President Lyndon Johnson signed designated February as American Heart Month to acknowledge and combat the “staggering physical and economic loss to the nation” caused by cardiovascular disease.

Unfortunately, that proclamation is proving to be a timeless document.

Even with broad awareness of heart disease, expansive research and a number of clinical and public health efforts to prevent, diagnose and treat cardiovascular conditions, it remains the leading cause of death in the nation. About 600,000 people die from heart disease in the United States each year—making it responsible for one out of every four American deaths.

As a research institute dedicated to helping patients and those who care for them make better informed decisions that lead to better outcomes, the Patient-Centered Outcomes Research Institute (PCORI) is acutely interested in producing new information that supports more effective cardiovascular care. The directive in our establishing legislation to consider “disease incidence, prevalence, and burden” when prioritizing research funding is a clear call for studies of cardiovascular conditions.

I’m proud to say that PCORI has answered that call. Cardiovascular disease, including heart disease and stroke, is the most commonly studied topic in our research portfolio. It is addressed in several dozen of the 192 primary research studies that PCORI has funded to date, including projects that conduct a comparative assessment of heart disease interventions, as well as those that test the effectiveness of decision support tools. Communicating information and providing tools to patients in ways that motivate them to make healthy choices is often a major challenge for clinicians.

Our comprehensive approach funds research that addresses the gaps in both information and communication that are responsible for poor outcomes in cardiovascular care.

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Why Transparency Doesn’t Work.

The Cleveland Clinic is by far the best provider of cardiac care in the nation. If you have cancer there is no better place to be than Texas. Johns Hopkins is the greatest hospital in the America.

Why? Because US News and World Report suggests as much in its hospital rankings.

But which doctors at the Cleveland Clinic have the highest success rates in aortic valve repair surgeries? What are the standardized mortality rates due to cancer at University of Texas MD Anderson Cancer Center? Why exactly is Johns Hopkins the best?

We don’t have answers to these types of questions because in the United States, unlike in the United Kingdom, data is not readily available to healthcare consumers.

The truth is, the rankings with which most patients are familiar provide users with little. Instead, hospitals are evaluated largely by “reputation” while details that would actually be useful to patients seeking to maximize their healthcare experiences are omitted.

Of course, the lack of data available about US healthcare is not US News and World Report’s fault – it is indicative of a much larger issue. Lacking a centralized healthcare system, patients, news sources, and policy makers are left without the information necessary for proper decision-making.

While the United Kingdom’s National Health Service may have its own issues, one benefit of a system overseen by a single governmental entity is proper data gathering and reporting. If you’re a patient in the United Kingdom, you can look up everything from waiting times for both diagnostic procedures and referral-to-treatment all the way to mortality and outcome data by individual physician.

This is juxtaposed to the US healthcare system, where the best sources of data rely on voluntary reporting of information from one private entity to another.

Besides being riddled with issues, including a lack of standardization and oversight, the availability of data to patients becomes limited, manifesting itself in profit-driven endeavors like US News and World Report or initiatives like The Leap Frog Group that are far less well-known and contain too few indicators to be of real use.

The availability of data in the United Kingdom pays dividends. For example, greater understanding of performance has allowed policy makers to consolidate care centers that perform well and close those that hemorrhage money, cutting costs while improving outcomes.  Even at the individual hospital level, the availability of patient data keeps groups on their toes.

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The FDA Ban on Trans Fat Should Be Just the Beginning

It’s been clear for more than a decade that trans fat is a dangerous substance that increases the risk of heart disease.  Denmark banned its use in 2003.  Several American cities and states have followed suit, but the use of trans fat is still widespread despite the availability of suitable substitutes.

Over the past 10 years, trans fat consumption is thought to have contributed to an estimated 70,000 needless American deaths. Given  that universal, voluntary cooperation to eliminate trans fat hasn’t happened, the Food and Drug Administration (FDA) is justifiably seeking to designate trans fats as unsafe.

A nationwide ban on artery-clogging artificial trans fat is a long-overdue first step toward improving American diets, fighting obesity and limiting the risk of chronic disease. But it is just the first step in what should be a far broader campaign to help consumers make healthier choices at mealtime.

Public lack of awareness of the impact of prepared foods on individual health is not limited to trans fat.   When dining out, even in establishments that avoid trans fats in preparing food, Americans face a range of health risks often without realizing it. People are routinely served far more calories than they can burn.

They are routinely served too many low nutrient foods and insufficient quantities of fruits, vegetables, and whole grains.  What should become routine instead is the availability of menu options that put people’s health first.

Hopefully, the FDA’s trans fat initiative will succeed – previous city/state bans and labeling improvements have already managed to cut daily consumption by Americans from 4.6 grams in 2006 to 1 gram in 2012 – and pave the way for the creation of other standards and regulations regarding the quantity and quality of food that is offered to diners in restaurants.

The lack of such standards makes it difficult, if not impossible, for most people to recognize when they are being put at risk for a chronic disease.   If people are served too much of something (like calories), they would have to compensate by eating less later; conversely, if they are served too little of something (like vegetables), they would have to eat more later to neutralize the risk of chronic disease.

But most people lack the information they need to judge or track the quantity and quality of the nutrients they consume.

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My Return to American Health Care

A year and a half ago, my husband, James Morgan, and I moved back to the U.S. after living 10 years in France.

We returned more or less kicking and screaming. We had been away long enough to lose some of our American culture and to prefer the European way of life, despite our squabbles with it–and every American abroad has some squabbles. I had discovered I was a born expat, something I’d suspected my entire adult life — from my first trip to Europe when I was 19 years old–but hadn’t arranged to test until my younger daughter graduated from high school. Jim and I are both writers, and I’d thought of a book idea for him (Chasing Matisse) that would take us to France, and my intention was for us to stay there.

But there were things we’d left undone for the 10 years we’d been away that needing tending to — life was calling us back. And if the truth be known, I felt France was falling behind in the world, and her inability to change was grating. Paris was stuck in her perpetual stupendous, effervescent beauty, while nothing new happened there at all. This city I love more than any other had long since lost the artistic dynamism that had propelled it forward with Picasso, Matisse, and the other artists that the Lost Generation had adopted and promoted in the early part of the 20th century, when Malcolm Cowley wrote his classic Exile’s Return.

The World Wars had crippled France for a time, and she had gotten back on her feet. But what the French do so very well is the past — not the present or future — and this is even truer in our digital global society. The French refusal to change defines the Gallic nation in every way imaginable, and the centuries-long celebration of their grand culture is what we love about them — and is also placing them in the rear of the international pack.

Except for this — their Number One in the World (as determined by the World Health Organization) health care system.

One of the things I most dreaded about returning to America was having to deal with a health care system that was an embarrassing national wreck.

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One Man’s Quest to Sign Up for Obamacare

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Day 4:

After spending more than two hours in the waiting room, I once again tried to create an account at healthcare.gov so my family could #GetCovered – as instructed by President Obama and Secretary Sebelius.

My first attempt at setting up an account today was thwarted when healthcare.gov said the user name I attempted to use was no good:

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Ack! It says the username already exists? This was the username I had set up on Day One (backstory here), but the system ultimately didn’t recognize it. I feared some other Tony Jewell had used my cleverly placed underscore.

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After the Navy Yard Shooting: A Call to Action On Mental Illness


The Navy Yard shooting in Washington, D.C. has once again confronted us with the issues of guns and mental illness, but what we really should address is the inadequacy of mental health care in the United States. Since 2009 there have been 21 mass shootings and the perpetrators in over half of these were suffering from or suspected to have a serious mental illness like schizophrenia, bipolar disorder and depression. (The other killers with no signs of mental illness were ideological zealots, disgruntled employees and disaffected loners.)

After each incident there is a great hue and cry, and calls for action but no substantive action is taken. Our reflexive approach has repeatedly failed to provide care in a timely fashion to individuals in need. As a country, we continue to ignore the growing public health need for greater access and a more proactive approach to mental health care. It is time that we say enough is enough and do something to prevent future tragedies.

When you strip away the hype and politics, the causal factors in these horrific incidents are clear and solvable. Yet we’ve lacked the social and political will to fashion and apply the solution.

The plain truth of the matter is that we do not provide adequate services to the 26% of the U.S. population with mental illness. The scope of and access to mental health services available to most people are limited and fragmented. Moreover, insurance coverage is all too often lacking and discriminatory. Consequently, we do not provide the level and quality of care of which physicians and health care providers are capable. It is the equivalent of knowing that a woman has breast cancer but not offering the indicated treatment options of surgery, radiation and chemotherapy. The result is that many people go untreated or inadequately treated.

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Pathologizing the Human Condition

The American Psychiatric Association recently published a new version of the Diagnostic and Statistical Manual (DSM). The DSM-5 is what medical, mental health, and chemical dependency professionals use to diagnose developmental, mental health, substance abuse and dependence, learning, and personality “disorders.” Now in its 5th edition, the DSM was first published in 1952. At that time, the DSM was 129 pages containing 106 diagnoses.

Now, 61 years later, the DSM-5 consists of approximately 950 pages and roughly 375 diagnoses. The DSM-5, while researched far more than previous editions, is based on the medical model or the model of disease. Simply put, the medical model finds the causes of disease and illness and then prescribes a treatment to cure the disease or illness. This means a person has a pathology or pathogen that needs to be treated and cured.

The questions that eat at me during my day as a psychologist and at night as a person searching for answers are:

  • Is it possible to accurately identify mental health “issues,” “illness,” or “disorders?” versus extreme ranges within the sphere of the human condition?
  • Even if it is possible to identify these conditions, does it determine the course of “treatment” or “intervention?”
  • If so, is there a “treatment” for every identified “condition?”
  • Does it mean there is a treatment that works?
  • Do you need a diagnosis to get help?

Over the years, many have been critical of this approach to mental “health” issues. Referring to mental “health” is actually a newer name as people have historically been thought to have mental “illness.” This makes more sense for people who are unfortunately compromised by severe conditions termed schizophrenia, bi-polar (manic-depressive), and severe depression and anxiety. But does this make sense for children, adolescents, and adults who are challenged with some other, and possibly less severe, aspect of their functioning and development? Do all human problems warrant a medical or mental health diagnosis? When did a weakness become a “disorder” that requires “intervention” and/or “treatment?”

To be fair, the DSM provided structure and guidelines for approaching the complicated business of determining who had a “problem” that required help. However, it seems things have gone too far. Critics of the DSM believe that this latest edition has taken the business of diagnosing to a new level, one where approximately 50% of the population can be diagnosed with something. Critics also believe that this pathology finding approach supports the continued trend of medication prescribing as the number one mode of treatment, and continued trend of increased health care costs and premiums with increased utilization of individuals who need a “diagnosis” to meet “medical necessity” to receive services. What does that mean? It means if you don’t have a diagnosis, you don’t get help. It means you have to have a problem (pathology) to get help (treatment and intervention).

Without going into detail about some of the changes in the newest edition of the DSM, some diagnostic categories have been added and some diagnosis “thresholds” have been lowered. This means that you need fewer symptoms to “meet diagnostic criteria.” Here are some examples of concerns with the new DSM-5:

  • Temper tantrums will now be diagnosed as Disruptive Mood Dysregulation Disorder
  • Normal forgetting will now be diagnosed as Minor Neurocognitive Disorder
  • Gluttony will be diagnosed as Binge Eating Disorder
  • Grief will be diagnosed as Major Depression
  • First time substance users and college partiers will get a diagnosis of Substance Use Disorder
  • Everyday Worry will be diagnosed as Generalized Anxiety DisorderContinue reading…

Aligning Physician Incentives Doesn’t Do It

My wife Mary and I recently got a series of early morning calls alerting us to the declining health of Mary’s mom, who was in her 90s. She died later that week. We were stricken and so sad, but took comfort that she died with dignity and good care on her own terms, and at her home in San Francisco.

Ten years ago, we received a very different early morning call, about my father.  An otherwise healthy and vigorous 72-year-old, Dad had fallen at home. Presuming he’d had a stroke, paramedics took him to a hospital with a neurosurgery speciality rather than to the university trauma center. That decision proved fatal.

A physician in Seattle at the time, I arrived the next day to find Dad in the intensive care unit on a ventilator. Dad’s head CT revealed a massive intracranial hemorrhage. Dad also had a large, obvious contusion on his forehead.

The following day, the physicians asked to remove Dad from the ventilator.  He died that night. We were profoundly devastated by his death and upset with the care he’d received.

Our family wasn’t interested in blame or lawsuits. We did, however, want answers:  Why hadn’t Dad been treated for a traumatic injury from a fall? Shouldn’t he have had timely surgery to relieve pressure from bleeding? What went wrong?

I’ve spent the last decade searching for answers, for myself and countless others, to questions about how to improve health care.  I’ve had the honor of working with many people pushing health care toward high value, at the Robert Wood Johnson Foundation(RWJF) and elsewhere.

We’ve worked hard to find solutions.  We all get it:  The health care problem is a big, complex one without silver bullet answers. Still, we’ve made incredible progress with efforts like RWJF’s Aligning Forces for Quality Initiative in which community alliances work to improve the value of their health care.

We’re searching for ways to help us all make smarter health care decisions.  We’re helping health care professionals improve and patients and families be more proactive.  We’re exploring the price and cost of care, and ways to automate health care information with technology.

And importantly, we’re working to align the incentives that health care professionals need to support and deliver great care.  We strongly believe that unless we reward great results, we won’t get them.  That means payment reform, with a focus on financial incentives for those who hunt for waste, resolve safety problems, sustain improvement, and, most of all, innovate to save more lives.

But do financial incentives to promote and reward behavior work?

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The EHR Debate: Fighting the Last War?

Right now there’s a fierce debate going on for the hearts and minds of health IT. Finally American health care (well, half of it anyway) is using electronic medical records. But it’s not the panacea we were lead to believe. Costs haven’t gone down, health hasn’t markedly improved and the taxpayer/Chinese government is poorer. So too are many doctors and hospitals, and the main beneficiaries appear to be construction companies in Madison, Wisconsin.

Worse, those who promote the impact and importance of EMRs (Farzad MostashariAshish Jha) are being attacked by Ross Koppel, Steve SoumeraiScott SIlverstein and others who essentially say that EMRs are more dangerous and inefficient than paper.

This reminds me of the World War One British Army preparing to fight in the mud of Flanders with cavalry charges suited to the Boer War, the French Army in 1939 retreating to their WWI style trenches while the Germans flew over them, and (dare I say it) today’s TSA strip searching grandmothers looking for boxcutters.

Yes, we’re having the wrong fight by focusing on old problems. The EMRs that are producing the studies we’re fighting about are the current equivalent of 1990s EPR implementations. In general they’re hard to use and require lots of money and training to produce halfway decent results. The real improvements from IT came when user-centered tools came to consumers and then to business with Web 2.0 and new devices like the iPhone.

It may take months of training on Epic or Cerner to get a doctor or nurse to be three-quarters as productive as they used to be, but my two-year-old daughter can fire up an iPad and play games and watch videos with no training.What we’re seeing every day at Health 2.0 is a whole new generation of data-driven applications and devices that are going to make the health care user experience much more like the one my daughter has.

When we get there, the real improvements in both productivity and safety, as well as in quality and even cost, will emerge and we’ll wonder why we ever were having this fight.

The GOP’s Endless War on Obamacare-and the White House Delay

The official reason given by the Administration for delaying, by one year, the Affordable Care Act’s mandate that employers with more than 50 full-time workers provide insurance coverage or face fines, is that employers need more time to implement it. The unofficial reason has more to do with the Republicans’ incessant efforts to bulldoze the law.

Soon after the GOP lost its fight against Obamacare in Congress, it began warring against the new legislation in the courts, rounding up and backstopping litigants all the way up to the Supreme Court. Meanwhile, House Republicans have refused to appropriate enough funds to implement the Act, and have held a continuing series of votes to repeal it. Republican-led states have also done what they can to undermine Obamacare, refusing to set up their own health exchanges, and turning down federal money to expand Medicaid.

The GOP’s gleeful reaction to the announced delay confirms Republicans will make repeal a campaign issue in the 2014 midterm elections, which probably contributed to the White House decision to postpone the employer mandate until after the midterms. “The fact remains that Obamacare needs to be repealed,” said Senate Republican leader Mitch McConnell, on hearing news of the delay.

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