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Wednesday, June 30, 2010

The ambulatory care revolution begins

There is a great article in the NYT today:

Getting Treated for Common Ailments Online

If a Zipnosis patient is using a smart phone with GPS, they can touch a button and their prescription will be electronically sent to the nearest pharmacy or the pharmacy of their choice.Park Nicollet Health ServicesZipnosis patients using a smartphone with G.P.S. can touch a button and their prescriptions will be electronically sent to the nearest pharmacy or the pharmacy of their choice.
In a recent Bucks post, “Doctors, Let Me Pay You for E-Mail,” my colleague Ron Lieber said he would gladly pay his family doctors a flat annual fee to be able to e-mail them questions and get a timely electronic response, and he questioned why this isn’t the norm.
Well, it turns out that it’s possible now in one state, Minnesota, to pay $25 and then actually get treated for certain basic ailments online thanks to a just-introduced  yearlong pilot program offered by the health care provider Park Nicollet Health Services and, a start-up in Minnesota.

The idea is elegant and simple. Pick a short list of illnesses which affect normally healthy people and make them acutely uncomfortable:
1. Colds
2. UTI
3. Yeast infections ... 
to name but a few.  Have patients fill out a form online to sort out potential high risk situations. Address the concern for modest fee (slightly less than an office visit co-pay) which does not involve insurance.  Everyone is a winner. The patient is spared a visit and the time required at a financially neutral cost. The physician does not have to support a bricks and mortar overhead, has an encounter which is all but completely documented by the patient, and collects the money with basically no transaction costs associated with filing a claim. The insurer doesn't have to pay for the visit. The claim is this is not particularly lucrative. Once the information systems are in place and it is scalable, it can almost be automatic and the overhead approaches zero. 
The requirement for this type of care is two fold. The diagnosis and  treatment must basically be rules based and the stakes must be relatively low. The other feature of this is this will yield a huge amount of data in a format which can be easily queried. Data is power. I predict this will become the norm for addressing common acute problems in essentially well people so fast it will make our heads spin. 

Mencken was right

A funny thing happened on the way to improving our health care system. Sometimes the simple and the obvious is not so simple and obvious. In an interesting piece in the Health Affairs blog:

Is The Impact of Comparative Effectiveness Reports Being Evaluated?

June 30th, 2010 
"It is clear to all informed persons that the nation needs better evidence of what works in health care, and this has propelled comparative effectiveness research (CER) policy developments of late.  However, for a number of—mainly political—reasons, recent Federal legislation separates the process of evidence generation and evidence synthesis from policy processes, e.g. Medicare coverage or clinical guideline development.  With no direct link to health policy processes, the question occurs: is the evidence used in health policy decisions, and if so, how and what difference does it make? "  

OK- let's cut to the chase...The conclusions of the study were:

"In this study we were unable to document a single instance where the impact of a traditional evidence review was evaluated and made publicly available.  Additionally, no known systematic effort has been made to document whether such evaluations have occurred; thus this study can serve as a call for such efforts to take place."

I am not at all hostile to investment in comparative effectiveness research. My problem is how this information may be deployed to use heavy handed top down approaches to attempt to change behavior en mass.This will be done and efforts to measure actual impact with be late in coming if at all. This particular phenomena is not unique to medicine. It is basically the modus operandi of various regulatory entities which bedevil or professional lives. The ACGME creates reams of rules regulating the training environments for new physicians and have yet to put in place any program to identify their efforts have yielded an improved product. Fewer deaths with limited resident work hours? No empirical evidence whatsoever. Let's reduce hours further. Create impossible to measure competencies and impose them on training programs without a lick of evidence they serve anyone but the regulators purposes.

 In the wake of the Enron Scandal the Sarbanes-Oxley rules created am entirely new universe of financial regulations which was followed by even bigger financial scandals. Response??? More regulation without any methods to define effect. Calamity results in response without the tools to assess whether the response actually addresses the calamity in any way shape or form.  

My own take on this is for the most part people have no idea how things work. We are often not interested in fixing anything. We are more interesting in responding since it makes us feel good and it is easy for us to convince ourselves that we both understand and are empowered. H.L Mencken summarized this well when he wrote:
"For every complex problem there is an answer that is clear, simple, and wrong."

Sunday, June 27, 2010

The end of information asymmetry as we know it

It has been almost 50 year since Kenneth Arrow published his work entitled "Uncertainty and the welfare economics of medical care". The concept of information asymmetry and its impact on health care was introduced. This concept has fundamentally shaped our view of doctor patient relationships and our obligations as professionals. However, the world is changing and so must our views on how information asymmetry affects doctor-patient interactions.

When Arrow wrote his essay, medical information was a scarce commodity and difficult to acquire and vet. Physicians, through their extended training, experience, and professional networks had virtual monopoly control over the information required to make medical decisions.  As I see it, this environment of asymmetric distribution of information fostered a paternalistic relationship between doctor and patient. Since patients could not realistically be viewed as getting access to nor synthesizing the information required to make informed decision regarding their health, physicians were entrusted to make such calls. Until recently, this process was not widely questioned.

My practice has changed dramatically in the past five years in terms of what information I can and do access and how I use that information. Where I used to go to the medical library to pull articles, I simply go on line. Furthermore, more often than not, I access non-proprietary information. This means I am reading the same information that my patients have access to. I refer to this phenomena as the first medical reformation, likening it to when the printing press allowed greater access to the Bible by non-clergy.

While some view this as a threat, I see opportunity. When discussing options with patients, I often defer implementation of treatment for non-urgent problems, instead directing them to well moderated internet sites with vetted information regarding their specific ailments. They often find elements of information which fail to register with me as important. For certain patients with certain chronic diseases, they may link into disease communities which hold vast stores of information crucial to coping with chronic disease, something that is essentially missing from our training as physicians.  I fully understand that over time, many of my patients who are singularly focused on a single disease may become more of an expert on that given disease than I am. I treat some very smart, motivated,  and insightful patients.

Perhaps one of the most important areas where the disappearance of information asymmetry may have a profound impact is the development of  guidelines of care.  This is an arena which has taken on substantial importance for a number of reasons, not the least of which is they are being linked to quality metrics which then linked to payments for services. Guidelines are all about data and interpretation of data. The data used is ideally controlled trials for whatever intervention (diagnostic or therapeutic) is being considered. If high quality data already existed, the development of guidelines would not be so problematic. However that is simply not  the case.

We are left with the situation that we are being called upon to measure something important but we are not really sure what is important. Furthermore, we have not really decided who should decide what is important. In the previous era where information was scarce and could realistically be interpreted by highly trained professionals, it made sense that they be the primary agents involved in the development of guidelines. However, that is almost certainly not the case now.  In a world where physicians and other health professionals no longer have exclusive access to the vast majority of information required to make clinical judgments, what set of skills and attributes can justify their continued control of this process?

There is a paradox (no pun intended). Guideline development heavily focuses on Grade A evidence; hard data, controlled trials, and not anecdote. What physicians have, that the public does not, is experience and from this experience, intuition. Within the world of evidenced based medicine and guideline development, this doesn't count for much. It makes me wonder what the future holds for the medical profession. What will we do in the future which will bring value to patients?

This time is different

The just finished the Book "This Time Is Different: Eight Centuries of Financial Folly" by Reinhart and Rogoff. I can't say it was written for general public consumption. It was both data rich and poor simultaneously. They did a remarkable job of amassing financial data dating back hundreds of years .However, there were large gaps in the database and many assumptions regarding how to fill in these holes.

The lessons of the book were actually very straight forward and included:
1. All entities both private and public have immediate vested interests in hiding financial data, particularly relating to debt. This makes historical assessments regarding the role of debt in financial meltdowns difficult.
2. Financial meltdowns of various types (bank defaults, sovereign debt defaults, currency debasements) tend to be preceded by increased amounts of debt, financial bubbles (especially real estate), and relaxation of financial regulations (innovations).
3. The frequency of defaults of various types throughout history is much higher than we are led to believe and contemporary financial structures may not have lessened the frequency of impact of economic meltdowns.
4. The timeline for the development of financial meltdowns is unpredictable in that debt expansion and asset inflation may go on for an extended period of time before the meltdown events actually unfold.

Perhaps the most striking conclusion I can draw from their findings relates to how we might deploy strategies to avoid financial meltdowns. As the title implies, at any given point in time, one of the characteristics which marks the times prior to economic calamity is the "This time is different" mentality. The very development of tools to prevent events such as the Great Depression or The Second Great Contraction may very well increase the likelihood they will happen again. Perhaps the best defense against such events is the understanding that they can happen which serves to temper our use of debt and leverage.

Tuesday, June 15, 2010

The risk of not having catastrophes

There was a rather remarkable letter to the editor published in the WSJ last Friday by Terry Barr, President of Sampson Oil and Gas. It was not the usual 150 words but an extensive piece which took up much of the page on the main opinion and described a detailed timeline surrounding the events leading up to the catastrophic explosion, fire, and subsequent oil leak. The events are unambiguous. The catastrophic events were a clear consequence of not one but a series of bad decisions and activities executed on that fateful drilling platform.

Why would anyone or any group be so reckless? Perhaps the answer is we tend to become reckless when we are not aware that our behavior is risky. We tend not to become aware when "risky" behaviors virtually never result in bad outcomes. Bad outcomes serve a useful purpose when we are able to link specific behaviors to particular risky activities.

When we are successful in avoiding catastrophic outcomes, we tend to forget how are actions may cause such events. We start to believe that the world has become domesticated and somehow the world has changed in such a way that we were no longer vulnerable to such things as oil spills or financial meltdowns. Furthermore, we also lose the tools to address such unpleasant events. Who should BP turn to with experience in capping such a deep well and cleaning up the horrible mess? Who is around who has experience in dealing with such a calamity? The last major oil spill was almost 20 years ago during the first gulf war.

Over time, we lose both the expertise needed to deal with such calamities as well as our appreciation for the importance of safety measures to avoid them in the first place. In the realm of the financial world, it is pretty clear that excessive debt and leverage sets the stage for investment bubbles and financial collapse and it has done so repeatedly. Yet in the periods of time between calamities, memory of this fades, particularly when nothing happens to those who extend themselves. Leverage and debt be be used to make people very wealthy and periods of economic expansion coupled with measures to insulate people and institutions from modestly bad economic decisions ultimately entices many people to become reckless.

After catastrophes, we tend to deploy many control measures, some of which are more critical than others. Over time, we tend to forget what rules are critical and what rules are followed out of simply habit.  The longer we avoid spectacularly bad outcomes the less vigilant we become and the less we tend to appreciate what control measures are really important. With enough time, no one really remembers what behavior is really reckless. I would venture to guess that virtually no one within BP has experienced such an event. We can only hope that re-exposure results in some sort of lasting immunity. How can we artificially deliver such a booster without having to live through these events?

Thursday, June 10, 2010

More medical mythology debunked

The ASCO bizarre bazaar

I am simply left speechless....

Just when you can't imagine a more bizarre world, things simply get stranger. Where will we end up next.

Price transparency and the rebar steel of health care

A colleague of mine sent me a link to a NY Times piece;

Bringing Comparison Shopping to the Doctor’s Office
Published: June 10, 2010

It highlights some important steps on the road to price transparency. However, the final line contains a telling statement which reveals just how naive the author is.
At this stage, Castlight works best for big companies that are self-insured and for outpatient doctor visits for which quality does not vary greatly.
It makes sense that shopping on the basis of price is most applicable to the realm of medicine in which patients have the most time to look for what they want and look for deals. However, to state that quality in the ambulatory medical world does not vary is hard to fathom. A more accurate assessment is that quality in the ambulatory world is not consistently measured. Castlight appears to recognize this fact since earlier in the article it is note:
Castlight plans to add quality measurements to its price information. There are already several providers of that information, though there is no standard set of quality measurements in medicine. 
This again reminds me Clayton Christensen's analysis of the entry of the mini-mills into the steel industry. They entered the markets by making rebar steel where they could compete purely on the basis of price. No one cared that the steel made was of poor quality since there were basically no specifications, no one was equipped to measure quality, and the product was buried in concrete to top all things off.

In the ambulatory medicine world, what measures that exist are at best  poor proxies for something else desirable. Few patients would recognize that these quality metrics bring any real value to them as well for the simple reason that the links to them personally are tenuous at best. Many patients may need to be treated for many years for a few to actually benefit.  Measures of immediate and consistent impact would require validated measures of diagnostic accuracy and the ability to measure whether medical encounters actually solved problems. At this point in time ambulatory measures focus on surrogate markers such as blood pressure, hemoglobin A1c, and vaccination rates. These are perhaps great interventions to decrease the rates of illnesses at some future point in time. How about measures which assess how well we are doing in alleviating problems in the here an now? They basically don't exist.

The product of this situation is starkly simple. What cannot be measured is basically ignored.  Ambulatory medicine is the rebar steel of health care. The quality of ambulatory medicine varies hugely. You can make a lot of money in the ambulatory realm. It requires volume and no particular keen eye toward quality. Make it by the ton, price it to sell,  and as long as no one can measure specifications, your business model will be robust.

Sunday, June 6, 2010

The power of unfocused data collection

One of the most frustrating elements of practicing medicine is the how often I am required to admit that I don't know. In particular, I am most frustrated when a reasonable and intelligent patient poses a logical question regarding the natural history of some common disease and I must reply by saying we simply don't have good information to address such a question.

Much of the data on frequency of disease, particularly in ambulatory contexts, comes from administrative and billing databases. They were not set up to be used to study disease frequency but mostly to track the collection of money. We are fortunate that someone decided to add a few additional data fields for whatever reason. They are limited since the diagnostic data and classification schemes used are very flawed.

There are many additional examples of how broad collection of data or samples resulted in huge dividends years later in realms that could never have been anticipated when the collections were started. Serum and tissue banks historically were initiated for essentially open ended purposes. When new pandemics erupted such as HIV presented, serum banks were used to look for where the disease originated. When new models of disease pathophysiology are considered, tissues banked for other purposes allows for rapid testing of hypotheses.

The same applies to data collection. Perhaps no other entity embodies this better than Google. They are data hoarders like no other. They do not make decisions regarding what they save. When the time comes to look at an interesting question, they do not worry about whether they  saved the relevant data. They simply save everything. Last year an article was published in Nature describing how by simply looking at Google cold and flu queries they could demonstrate where influenza outbreaks were occurring, well before the CDC tracking system identified these peaks.

Within the world of clinical research, we have good news and bad news. The good news is we have data collection and analysis tools which make things possible which were simply not possible before. The bad news is what we are called upon to do before we can deploy them. Because of privacy concerns, we are now asked to define what information we want to collect and why. I would argue that if we have learned anything in the recent past it is that we cannot anticipate what element of what we collect (whether data or samples) will be of most value and the best collection strategy is to collect as much as possible. Key breakthroughs in understanding may simply happen as much through chance as anything else. Chance favors the prepared and in the world of data, being prepared means you have collected the data.

Conspiracy of silence

I always enjoy the Sunday posting from the MD Whisteblower.  Today, he wrote a piece on unnecessary medical testing, particularly issues revolving around referrals for imaging and diagnostic procedures. He describes a particular scenario where a patient presented with minor rectal bleeding :

I have never liked serving as a technician gastroenterologist, but I am often asked to do so. Like every other gastroenterologist, I have performed requested procedures that were reasonable, but that I would not have personally recommended if my advice had been sought. The patient referenced at the top of this post was in a different category. This was not a 'gray area' issue.

This particular patient was having some minor rectal bleeding. He had already had the pleasure of a full colonoscopy this past November, when hemorrhoids were discovered. No additional testing was necessary for the current minor bleeding, as hemorrhoids were the likely culprit. The request for an EGD was nonsensical. The ordering physician had no economic conflict of interest in ordering the test; only the gastroenterologist would benefit financially. An EGD here was like ordering a foot x-ray on a patient with a sore throat.
This scenario raises so many questions it is hard to know where to start. The major questions that come to mind are:

1. Who do you work for in this circumstance?  
2. What job were you hired to do?  

Until it is clear what the answers are to these questions, all other discussion are essentially moot. Let us address the first question. Most economic transactions are fairly straight forward since there are generally two parties, a buyer and a seller. There may be a broker who facilitates the transaction but it generally pretty clear who the principal parties are. In a health care transactions such as described by the MD Whistleblower are extremely common and in my estimation the problem is the confusion relating to these two questions.

For a specialist who is dependent upon referrals, it is pretty clear that they are more beholden to their referring docs than to the patients who are referred. How else could you justify actually doing the equivalent of  a foot x-ray on someone with a sore throat. Because of the financial structures which have evolved in medicine, physicians are only marginally beholden to patients with some specialties essentially not beholden at all. 

The second question is inextricably linked to the answer of the first. If any given physician who has been pulled into the care of a specific patient is primarily working for someone other than the patient, the job they are hired to do may or may not actually provide any value to the patient. In the scenario described in this particular blog, the job the MD Whistleblower was hired to do was to reduce the exposure of the primary care MD to the legal risk of failure to diagnose. In this case there essentially no potential value to the patient. This unfortunately placed the consulting MD in a precarious position of either being a true advocate for the patient by revealing the absurdity of the consultation  and alienating his employer (referring MD) or continuing to play the game. 

I do not mean to pick on the GI field. The MD Whistleblower simply described a great scenario to use as a springboard. The same game happens ever day in other specialties. Overwhelmed primary care MDs send consult missiles to get patients out of their offices and relieve themselves of the responsibility of explaining the nuances of risk and the ability of testing to predict risks. Technically focused specialists are most highly rewarded for maintaining a state of blissful unawareness of anything that might prompt them to stop and convince patients that they do not need that EGD, CAT scan, skin biopsy, or cardiac catheterization.  

I believe the only way out of the quandary is to educate patients to ask these two basic questions whenever they have encounters with physicians. The answer to the first question will invariably that the MD claim he (she) has been hired by the patient. It might not be entirely true, but it will at least serve as a reminder how it should work. The answer to the second question is where things will get interesting. I can imagine the the conversation regarding the scenario described above with a patient who has been educated to ask the right questions.

Patient: What job am I hiring you to do?

Doctor: Your primary care MD referred you to me to do an EGD.

Patient: Why will this be useful to me?

Doctor: It might find an  undefined source of blood loss?

Patient: How likely is that to be the case?

Doctor: Vanishing small to non-existent. I will be happy to comply with your doctor's request. Is this what  you want me to do?

I can also imagine the more likely conversation going like this:

Patient: I had some minor bleeding and my doctor sent me for this test?

Doctor: Yes I know. Here sign this consent for the EGD. 

Patient: Can I really die from this test? 

Doctor: Not really, legal makes us include this language

What it boils down to is uninformed patients will always be prey. We would like to believe that the medical profession will be driven by altruism primarily. As much as it hurts me to admit this, there are cultural elements which permeate the business of medicine that most closely resemble cultural elements more commonly associated with used car sales. We are not going to change human nature and the best defense for dealing with this is informed consumers.

Tuesday, June 1, 2010

Dealing with complex new technologies

Kenneth Rogoff's piece in Project syndicate is very provocative.

In this piece, he identifies that the gulf oil spill underscores a much more universal issue:
The disaster, however, poses a much deeper challenge to how modern societies deal with regulating complex technologies. The accelerating speed of innovation seems to be outstripping government regulators’ capacity to deal with risks, much less anticipate them.
This issue is not limited to drilling for oil. It basically touches upon every aspect of a rapidly changing human existence where change is driven by leveraging technological progress. Every technology deployed to improve human existence has been accompanied by risk and trade offs. The harnessing of fire was one of the most monumental technological achievements  in all of human history. We are still dealing imperfectly with its risks.

It is easy to toggle between health care and non-health care worlds when reflecting upon upon positive and negative impacts of technology and innovation. Petrochemical based energy has been the engine which has released vast portions of humankind from the bondage of existences which are brutish and brief. In some respects, the present oil disaster can be likened to the rare horrible reactions to a miracle drugs such as drugs used to treat HIV. Should we ban abacavir since it can cause devastating and life threatening allergic reactions even when the number of people whose lives are saved vastly outweighs the rare and devastating impact of idiosyncratic reaction?

Within medicine, a dizzying array of technologies have been deployed within the past 100 years. When the risks of everyday life were so common that no one was particularly surprised when would randomly strike down healthy persons, risks of deploying innovative approaches to the treatment of life threatening illness was a no brainer. However, as we have decreased the risks of everyday life, we have also simultaneous altered expectations as to the promise of innovation and the benignity of its deployment.

Deployment of technologies sufficiently powerful to make a meaningful impact on human existence will always  be associated with risk. We will never be able to define rational policies and approaches to managing the risks until we recognize that there will always be trade offs and appreciate and understand both the quantitative  and emotional elements.