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Diabetes Updates - New Diagnostics, Increasing Rates, and Implications for Health Reform, CER, etc.

By Michael D. Miller MD
June 17th, 2009

Changes in the diagnosis and treatment of diabetes is a great example for understanding how healthcare delivery constantly evolves based upon new discoveries.  And the history of these changes may help illuminate some thinking about health reform and the development and use of comparative effectiveness research (CER).

First, a little background on diabetes.

Diabetes Background
Diabetes mellitus (or “sugar diabetes”) occurs when the body has problems regulating the level of sugar (specifically glucose) in the blood.  This can be because the body’s pancreas doesn’t produce enough insulin, or for some reason the person’s organs become resistant to the actions of the insulin that is present - or sometimes both occur simultaneously.  Impaired control of glucose means that the levels get too high, which produces problems in the eyes, (leading to blindness), in the kidney, (leading to kidney failure), and in the small blood vessels elsewhere in the body, which can lead to nerve damage and low oxygen delivery to the extremities - particularly the legs and feet, (leading to amputations).

In olden times, diabetes could be diagnosed by sugar in the urine.  (Medical lore says this was done by taste….)  However, until insulin was discovered in 1921 there were no therapies for severe insulin deficiency.  And even once insulin became available, sugar in the urine was still the way diabetes was diagnosed and monitored - usually with a dipstick that changed color depending on the sugar concentration.

It wasn’t until the 1960s that measuring blood glucose levels became possible - and only then in the doctors’ offices because the machines were large and expensive.  In the 1980s machines small and cheap enough for patients to monitor their blood sugar levels at home became available.  This enabled patients to start adjusting their own insulin dosages based upon their blood sugar levels.  (Before this it was too dangerous for patients to significantly alter their insulin dosages because while too little insulin leads to too high sugar levels causing long-term damage, too much insulin can drop sugar levels too low and lead to confusion, coma and death.)

In more recent years it was discovered that keeping diabetics’ sugar levels near normal could prevent essentially all the adverse consequences of diabetes, i.e. blindness, renal failure and amputations. But doing this based upon finger-stick blood sugar levels even 3 and 4 times a day was tricky - and those were just single data points.  So in the mid 1970s it was proposed that monitoring the amount of hemoglobin in the blood that had combined with glucose would give a measure of the average blood sugar level for the 2-3 month life of the red blood cells.  (It was known that glucose irreversibly connects to the hemoglobin in red blood cells in a way that directly correlates to the blood sugar level.)  This test, known as “glycosylated hemoglobin, (or HbA1C, or simply A1C), has been increasingly used over the past few decades to monitor diabetics and adjust their treatments, with the goal to keep A1C levels below 7%, since the level in people without diabetes is 4-6%.

Care Lags Discovery and Development of Innovations
Despite improved ability to monitor diabetes, it is still under diagnosed, and poorly managed.  It is estimated that there are about 6 million people in the US who have diabetes, but don’t know it - which is about 25% of all people with diabetes.  And in 2003-2004, only about 57% of people with diabetes had A1C levels <7%.  (The medical and lost productivity costs for all people with diabetes may be approaching $200 Billion.)

And the prevalence of diabetes is increasing - and with it so are the costs of treating people with diabetes. Last year I wrote about this, and now the CDC has updated information showing the continuing growth in the number of people in the US diagnosed with diabetes:

Increasing Rate Diabetes in the US 1980-2006
Source: http://www.cdc.gov/diabetes/statistics/prev/national/figpersons.htm

The treatment of diabetes has also changed.  After insulin was discovered, different forms and modifications where developed to change how quickly it acted, and beef and pork sources have been replaced with biotech “human” insulins grown in bacterial cultures. Many different types of non-insulin treatments for diabetes have also been developed - these act primarily by increasing insulin production from the pancreas or the action of the insulin in the body.

Which brings us back to the A1C test.  An International Expert Committee from the American Diabetes Association is now recommending that the A1C test be used to diagnose diabetes.  This would replace (or supplement) the traditional fasting blood glucose diagnostic test, and the A1C test would still be used for twice yearly monitoring of the adequacy of treatment for people with diabetes.

These developments in diagnosis and treatment have progressed in tandem - each leveraging off the knowledge gained from the other - with the A1C test being part of the continuing evolution of tests for diagnosing diabetes.  For example, the fasting blood glucose level for diagnosing diabetes has changed over the years.  It was originally set at 140mg/dl in 1979, and then lowered to126 in 1997, when it was also decided that a level between 110-126 should be considered pre-diabetic, or “impaired fasting glucose.” And in 2003 the lower bound for “prediabetes” was lowered to 100.

Why A1C Now?
While A1C testing has been used for years, there have been problems in standardizing the measurement. (This is discussed in the ADA paper linked to above.) But now A1C measurement inconsistencies, (which occur for all lab tests), have been narrowed sufficiently so that the ADA committee is recommending that an A1C level of >6.5% be used to diagnose diabetes, (for patients who are not pregnant and do not have hemoglobin abnormalities - these can change HbA1C levels significantly), and that people with A1C levels >6.0% and <6.5% be considered to have “subdiabetic hyperglycemia” because they have a significant risk of progressing to diabetes.

So Back to Health Reform and CER - The Challenges Ahead
The challenges ahead are to make sure that we continue to utilize future discoveries in a timely and intelligent way. Which finally brings us to health reform and CER. Health reform that expands insurance coverage should dramatically improve the diagnosis and treatment of people with diabetes - which should also help control other healthcare and societal costs because poorly controlled diabetes leads to many other costly problems.  However, immediate cost pressures present barriers to using the best diagnostic and therapeutic interventions.

Comparative effectiveness research is supposed to provide information about the best interventions, but as has been seen with advancements in diabetes, what is best often changes in progressive leaps based upon new discoveries.  And one of the limitations of CER, (and all research for that matter), is that it takes time to do the work and analyze the results.  Therefore, research really provides information about what was the best when the research started - which could have been several years before the results are known and disseminated.  And this time lag effect can be even longer when the research is based upon previously published studies or analyses of clinical records.

The lesson here is that while CER and similar research can provide very important and useful information, it must be put into the proper historical and clinical contexts.  What was state-of-the-art when the research protocols were developed may be 2, 3, 4 or more years out of date when the data is analyzed.  This reality needs to be considered when such information is used for coverage and reimbursement, and decisions about health delivery and financing system redesign.

I am confident that most insurers are not paying for A1C tests to screen people for diabetes - and that it will likely take a year or more for even the most progressive insurers to do so…. but they eventually will.  Which raises the question, what did they gain by waiting?  And what did they, (and the patients), lose?

Addendum: The hospital lab my doctor uses charges $59 for a HbA1C test.  So assuming that price doesn’t come down if more people are getting the test, the calculation needs to be made as to what is the ROI for using HbA1C as a screening test?  And the CER questions are how to identify people who would most likely benefit from HbA1C screening, and how to determine how frequently the screening should be done?

Posted in Comparative Effectiveness, Delivery of Healthcare, Economics & Financing, Health System Reform, Information & Communications, Quality of Care & Safety | No Comments »

Savings from Comparative Effectiveness Research

By Michael D. Miller MD
May 28th, 2009

The May 23rd issue of National Journal has two very interesting pieces about Comparative Effectiveness Research.

Scoring Savings from CER:
The first is in an interview with CBO Director Doug Elmendorf which includes this Q&A about scoring savings from CER:
“NJ: In the first five years after studying comparative effectiveness, are the savings that CBO can find relatively small?
Elmendorf: The estimates that we’ve done in the past suggest that by the 10th year, you are saving about as much as the cost of the research itself.  By the fifth year, you are not.  We would expect there to be savings in the private sector.  The federal government captures only a piece of that through the tax effect.  What I haven’t told you about is the net effect of comparative effectiveness research on national health expenditures.  That will tend to be a net saver for the country sooner.”

CER in Health Reform:
The next article in the NJ issue, (“The Risk of Comparing Treatments”), is about the possible inclusion of a new agency or independent institute to conduct or oversee CER. The legislative fate of such organization may hinge upon how CBO scores increased or continued funding for CER, and as seen above, it seem unlikely that CBO will attribute large savings to CER.

While scored savings from CER may be small, the fight about how CER should be used is getting hot.  The NJ article also discusses two new organizations that sound somewhat similar, but are actually on opposite sides of this issue: The Partnership to Improve Patient Care, and the Alliance for Better Health Care.  The former includes innovative companies and groups from industries such as biotech, pharmaceuticals and medical devices. While the latter includes health insurance plans, physicians and others.

Interestingly, patient organizations are divided between the two, with more disease specific groups who place a high value on the discovery of new treatments are aligning with PIPC, while broader “consumer” organizations that prioritize better information about existing therapies have signed on with ABHC.  Similarly, biomedical researchers could be viewed as split about CER, with academic researchers viewing the $1.1Billion in new CER money in the stimulus bill as a great opportunity for more funding, while industry researchers understand that the use of CER to make reimbursement and coverage decisions could reduce the incentives for investors to fund innovative private sector R&D.

So stay tuned.  The next event in the CER skirmishes will likely be around what the Finance Committee includes in their legislation about a new agency or institute for CER in the bill they are expected to unveil in a week or two.  Look for this issue, and other aspects of CER, to fuel one of the more interesting controversies within the health reform debate this summer.

Posted in Comparative Effectiveness, Economics & Financing, Health System Reform, Information & Communications | No Comments »

People in Health Reform & Transformation

By Michael D. Miller MD
May 20th, 2009

The importance of the “people factor” in improving the quality and efficiency of healthcare is well understood by experts in health information technology (HIT) and healthcare delivery transformation.  In estimating the time and cost for implementing new technologies or processes, they appreciate how behavior change and technology adoption are very time consuming and expensive – factors that are often glossed over in policy discussions.

David Brooks’ recent Op-Ed in the New York Times about the personality traits of CEOs leading successful companies sheds some light on the people factors in health reform.  Contrary to a lot of the common wisdom about the importance of good personal connections with coworkers for success in the corporate world, Brooks cites information that the most important factors for successful CEOs are “execution and organizational skills. The traits that correlated most powerfully with success were attention to detail, persistence, efficiency, analytic thoroughness and the ability to work long hours.”

He goes on to state that what produces effective CEOs are “emotional stability and, most of all, conscientiousness — which means being dependable, making plans and following through on them.”

In the medical world, this would describe most surgeons, but the difference between the corporate and medical worlds is that CEOs have greater direct control over their people and organizations than do the leaders of health delivery organizations like hospitals or clinics, which rely on the performance of many different professionals and skilled staff who function quite independently, such as doctors, nurses, and many types of therapists.  Thus, while “being a good listener, a good team builder, an enthusiastic colleague, a great communicator [does] not seem to be very important when it comes to leading successful companies,” in the clinical world, these traits are very important.

Brooks’ comment that, “business leaders tend to perform poorly in Washington, while political leaders possess precisely those talents — charisma, charm, personal skills — that are of such limited value when it comes to corporate execution,” correlates very well with my observations of senior corporate managers, politicians and clinicians.  I have seen business leaders who are successful in working the political circuit but have struggling corporate organizations, and politicians who enter the business world – often as leaders of lobbying or policy organizations in Washington DC – whose operations are chaotic and inefficient.

However, there are a wide variety or organizations in the healthcare universe’s 4 spheres, and the leadership qualities best suited for increasing quality and efficiency depend upon the sphere the organization is operating in, the type of organization, and the local culture.  For example, leading a biotech, medical device, diagnostic, HIT, or pharmaceutical company requires the type of hyper-focused “boring” CEO described in Brook’s column.  But successfully leading a hospital, clinic, or private medical office requires someone who has relatively stronger people skills.  And someplace in the middle would be the leadership of health plans which have to bridge the business and clinical worlds, and leaders of government agencies which have to straddle the policy and political arenas.

Keeping the importance of the people factor in mind while developing health reform and transformation proposals will help create realistic expectations and time lines – both for the actual transformation of care delivery and the ability to achieve cost savings.  For example, as CBO noted a year ago - and I’ve previously commented on - the ability of health information technology to achieve cost savings is dependent upon how those technologies actually change behaviors of clinicians, patients, and others - a process which is very time consuming and expensive.

Posted in Delivery of Healthcare, Health System Reform, Information & Communications, Quality of Care & Safety | 1 Comment »

Bridging the Valley of Death - Local Solutions

By Michael D. Miller MD
May 9th, 2009

A couple of weeks ago I wrote about translational research barriers - also known as the “valley of death” - and some larger, national public and private programmatic solutions.  This week’s Mass High Tech newspaper has a cover story about how Children’s Hospital in Boston created a $1 Million fund to help their researchers bridge that gap to take their discoveries into the development process that can actually lead to better patient care.

Two things caught my eye in this article.  The first was their actually using the term “valley of death.”  And the second was that this institutional fund illustrates how the best strategies for many health problems combine large & small, and national & local complimentary solutions.  Thankfully this has been the situation in many areas such as  biomedical research, (e.g. NIH funding, local and national charities, and individual institutional funds), and healthcare services for the poor, (e.g. Federal Medicaid funding, state administered Medicaid programs, national and local charities, and individual efforts).  The success and strength of these multifaceted approaches should be remembered as we seek to solve the entire range of healthcare problems in all four spheres of our healthcare system.

Posted in Innovation | No Comments »

Communicating with Clinicians to Improve Quality

By Michael D. Miller MD
May 8th, 2009

At a recent public forum on improving quality and value in healthcare, an audience member asked how can patients know if the treatment or diagnostic test their clinician is recommending is really the best thing for them.  This reminded me that the Agency for Healthcare Research and Policy (AHRQ), recently ppublished a two page tip sheet to help patients talk to their doctors and a web-page that helps people create a set of questions customized for their individual healthcare needs and situations.

While these are obviously useful tools, I realized that emphasizing patient-clinician communications is now more important than ever because of the growing trend toward “consumer directed healthcare” and “patient empowerment.”  While these types of activities and insurance product may be able to reduce costs by incentivizing people to use less healthcare, how they effect quality is still uncertain.  In addition, the enormous amount information available on the internet is making people well armed with data and facts, but not necessarily with knowledge.  Even with a lot of facts and data, patients are much better off having another person, (i.e., a trained clinician), integrate all the information about their individual situation and present a complete perspective and set of recommendations.  (This is why it is generally not appropriate for physicians to treat themselves or family members, i.e. because they cannot be both the patient - or family member - and provide an impartial and objective analysis.)

Asking Questions is Key for Communications and Quality Improvement
The AHRQ materials are valuable for improving the quality of care because patients may find themselves overwhelmed in a medical office, and forget to ask the right questions - particularly when faced with a new diagnosis or presented with a set of recommendations for treatment of an existing condition.  Coming to the medical office with a set of written questions will help remind the patient what questions they want to ask, and help promote a conversation with the clinician about the patient’s needs and desires. Clinicians are generally much more receptive to patients who ask questions than to those who just present opinions, requests, or demands about their treatment.

AHRQ’s “Talking with Your Doctor” tip sheet, has two key messages for both policy makers and patients:

  • Research has shown that patients who have good relationships with their doctors tend to be more satisfied with their care - and to have better results.
  • Write down your questions before your visit. List the most important ones first to make sure they get asked and answered.

Checking for the Checklist
AHRQ’s web-page for creating customized question lists is a valuable resource not just for preparing to talk with clinicians, but also for choosing health plans, hospitals, long-term care facilities - as well as clinicians.  While the list of suggested questions AHRQ is good, one item that I’d add is, “Does the hospital require the use of surgical checklists?”  (FYI - I’ve written about how such checklists have been shown to reduce errors and improve quality, and I’ve suggested that patients ask their surgeons and hospitals if they use them - and if not, why not?)

And apparently I’m not alone in promoting greater use of checklists in hospitals.  I recently heard that Health Care for All here in Massachusetts is pushing for legislation to require hospitals to use such checklists.  I applaud their efforts to highlight this quality improving measure, but also want to note that there are arguments on both sides for whether legislation is the best route to improve quality of care at all hospitals.  For example, how specific do we want laws to be in listing what hospitals and doctors are required to do, since laws can be difficult and time consumer to change?  Conversely, how quickly and completely will hospitals and doctors change their practices if they are not compelled to do so by new laws? And are their other mechanisms besides laws to make these changes faster and more completely?

Questions are the Answer
Whatever routes are used to improve quality of healthcare, (e.g. legislation, patient empowerment, financial incentive, peer pressure, etc.), it’s clear that patients, advocates, policy makers, and others need to continue asking thoughtful and focused questions.  As the website name for AHRQ’s customized questions list states, “Questions are the Answer.”

Posted in Clinician-Patient Relationships, Delivery of Healthcare, Information & Communications, Quality of Care & Safety | 2 Comments »

Improving Cancer Care in Medicare

By Michael D. Miller MD
May 5th, 2009

This week’s AMA News includes an article about how cancer care for Medicare beneficiaries has improved because of a provision in last year’s Medicare Improvements for Patients and Providers Act (MIPPA).  The provision of interest clarified that Medicare Part D plans need to pay for off label uses of medicines to treat cancer when there is supportive evidence in the peer-review literature.  This changes became effective January 1st, and for at least one patient, it has improved their care. (See the Medicare Rights Center’s press release about the coverage appeal they won for a client because of the new law.)

However, as I noted in an interview with the American Medical News ReachMD Radio-XM 160, (See MP3 audio file below), because the change only applies to cancer treatments, patients with other serious and life threatening illnesses may still find their treatment options limited.  That is, under current law, for non-cancer illnesses, Medicare Part D plans can still limit coverage to only the off-label uses listed in the standard compendia.

American Medical News ReachMD Interview May 5, 2009 - Off Label Coverage by Medicare Part D Plans
American Medical News ReachMD Interview May 5, 2009:
Off Label Coverage by Medicare Part D Plans

I had recommended that the MIPAA change go beyond cancer to include serious or life-threatening conditions - terminology that is somewhat imprecise, but widely recognized, including by the FDA. However, I suspect that because of cost concerns, this broader expansion of off-label coverage was not included in MIPPA.  I find this interesting for two reasons.  First, in these times of record government spending, even MIPPA’s limited coverage expansion for off-label cancer treatments raised some concerns about cost increases - which I wrote about in January.  And second, that restricting coverage of treatments in this way seems philosophically opposite to the intended benefits of Comparative Effectiveness Research - which is all about using the best research findings to improve the quality of care.  Of course, with the size of our health care system, I’m sure this won’t be the last time the left and right hands are not perfectly in sync.

Juggling Balls

Posted in Access to Healthcare, Comparative Effectiveness, Delivery of Healthcare, Innovation, Politics, Quality of Care & Safety, Therapeutic Substitution & Interchange | 1 Comment »

Business Perspectives on Comparative Effectiveness Research

By Michael D. Miller MD
May 2nd, 2009

Comparative effectiveness research continues to be a hot health policy issue for many companies and stakeholders, in part, because they’re concerned that CER information will be used to deny access to innovations because of cost.

I recently talked with Jeff Sandman, CEO of Hyde Park Communications, about how healthcare companies should productively approach CER issues, and how quickly CER would lead to dramatic changes in the healthcare system.  (See part of our conversation below.)

There will certainly be more reports, seminars, meetings and Congressional hearings about CER as the $1.1 Billion in ARRA funding for CER is distributed, and the results of that research begins to roll in. I’ve written about CER in the past, (see here and here), and expect to continue writing and talking about it in the future - and I would be very interested to hear anyone else’s perspectives on this issue and how they think it will impact the transformation of healthcare.

Posted in Access to Healthcare, Comparative Effectiveness, Delivery of Healthcare | No Comments »

Investment for Health Reform - Escaping the Valley of Death

By Michael D. Miller MD
April 30th, 2009

The debate about health reform has mostly focused on expanding insurance coverage and controlling costs.  However, successfully improving the US healthcare system will require some long-term quality improving investments.

The stimulus bill (ARRA) included two such investments.  The $1.1 Billion for Comparative Effectiveness Research has been widely discussed because it is important, and a very large percentage increase in the Federal Government’s spending in this area.  But the ARRA bill also included $10 Billion to increase NIH’s funding.

The significance of the increased NIH funding is twofold:  First, it will provide expansion of biomedical research related jobs.  And second, it will help the NIH increase the work it does in translational research, which should help biomedical research build a better bridge over what the Parkinson’s Action Network and others have labelled the “Valley of Death.”

Valley of Death
The Valley of Death, as described by PAN at a briefing last week hosted by FasterCures, is the work required to turn basic lab research discoveries into treatments that help people.  Some people call this “translational research,” and the NIH has been moving in this direction by funding institutional centers with Clinical and Translational Science Awards (CTSAs).  The two major activities that occur (or don’t occur readily enough), in the Valley of Death are prototype discovery and design, and preclinical development.  (See PAN’s graphic below.)

PAN Valley of Death -1

The Valley of Death is a real challenge because while these activities are vitally important for improving the quality of healthcare over the long run, the incentives for doing this work are smaller than for basic or fully applied research:  In the private sector, there may be small incentives for translational work, but in academia the incentives may actually be negative because successes in this area garner little or no professional prestige or recognition, and more importantly, generally doesn’t attract research grants, i.e. money to support the researcher’s lab and the university.

A Bridge to Better Care
Filling in - or bridging -  the Valley of Death, (feel free to pick your metaphor), is important for improving healthcare because there are so many serious conditions where current treatments are very inadequate.  For example, Parkinson’s is one of many neurodegenerative diseases where existing treatments address some of the symptoms - and often only partially or temporarily - without effecting the course of the illness.  Similarly, while significant advances have been made in treating cancer, those successes have been in select types of cancer, (with leukemia being one good example), or have made the treatments much easier for the patient.  Both of these are valuable, but it is also worth noting the recent article discussing how survival rates for cancer haven’t really increased over the last several decades.

The cure for this problem is clearly more (and better) research and development…. and the translational work that bridges the two. (Perhaps we should talk more about increasing R&T&D, rather than just R&D?) PAN’s description of how to do this is sophisticated and multifaceted.  As their illustration below shows, not only are the NIH’s CTSAs and SBIR programs important for helping institutions and individual researchers push forward with more translational work, but other parts of the solution include DoD’s Telemedicine & Advanced Technology Research Center, and private foundations and venture philanthropy.

PAN - Valley of Death -2

Increasing funding for translational work through all these sources may help build a bridge, (of fill in the Valley), but translational work will also benefit by greater coordination of efforts.  At the institutional level that is part of the role of the CTSA’s, but there could also be more coordination and emphasis of translational work at the NIH itself - which is why PAN is recommending the NIH conduct an analysis and present their own recommendations for improving the translational activities of NIH funded research programs.

Institutional researchers could also benefit by having more resources about the nuts and bolts of translational work - like how to structure research and information so that it will be readily usable for filing an IND with the FDA.  Universities already have Technology Transfer/Licensing offices that serve the dual function of licensing university generated research to private companies for commercialization and ensuring that the university receives fair compensation for the company’s use of these discoveries - which is required by the Federal Bayh-Dole Act.  Perhaps universities should also have offices that work to educate their researchers about translational activities to help them plan their research so that the information they generate will be more readily usable by those farther down the development pipeline?

This is clearly not an easy nor readily obvious task.  At the FasterCures/PAN briefing last week, someone told a story about an academic researcher who experienced a 2 year delay in moving their discovery along the development pathway because they didn’t understand the information that would be needed.

Rather than make specific recommendations about how to improve the situation for basic researchers, I’ll just note that the Bayh-Dole Act managed to get every institution receiving Federal grants to create a Technology Transfer/Licensing office.  It seems that every institution could also have a Office of Translational Research Assistance too.  How to structure the funding or financial incentives for this could be complicated, but certainly not impossible.  And given that we are spending tens of Billions of tax dollars on biomedical research, we should also be doing everything we can to make sure that the discoveries coming out of that research gets translated into better treatments for patients ASAP.  Delays because academic researchers don’t want to pitch their careers into the Valley of Death, shouldn’t be a tolerated part of the structure of our biomedical research system - which, as I’ve previously discussed, is one of the four spheres comprising our entire healthcare system.

Posted in Comparative Effectiveness, Health System Reform, Innovation, Quality of Care & Safety | 3 Comments »

Comparative Effectiveness, Efficacy, Evidence Based Medicine, P4P, etc…

By Michael D. Miller MD
April 6th, 2009

Comparative Effectiveness Research (CER) is being talked about more and more as a fulcrum for controlling healthcare costs.  For example:

  • The Congressional Budget Office issued a report on CER in December 2007 and has highlighted it in more recent analyses and reports about health reform options
  • The ARRA legislation included $1.1 Billion for CER
  • ARRA included language for the IOM Committee on Comparative Effectiveness Research Priorities to provide a report by June 30, 2009 about how to spend the $400 million allocated to HHS for CER.

All this discussion has kept me thinking about how CER will be done, how the results from this research will actually be used to improve quality and reduce costs, and what are the scope of healthcare issues that CER is, will, or should be applied to help improving.

While understanding what works best in healthcare is certainly a worthy goal, this is far from a simple task.  Some of the factors that complicate research to compare the effectiveness of various treatment options are:

  • Gold-standard double-blinded trials for clinical research provide information about efficacy - which is different than effectiveness.
  • Observational research can provide information about real world effectiveness, but the information from this type of research can be flawed by problems in the data - including selection biases and other conclusion skewing factors.
  • Both these types of research methodologies inherently have a lag between the time the research project starts and the time the data is analyzed and conclusions developed.   This time lag is often several years, during which new treatment options will likely have been developed.  Thus, CER really is only answering questions about the most effective treatment options when the study began, not when its conclusions are presented.
  • There is also considerable controversy about what factors to compare in CER projects.  That is, should only clinical outcomes be compared, or should costs be a factor?  And if cost is a factor, how are indirect costs, such as diagnostic testing, office visits, patient’s time, etc., included?  And how is quality of life valued?  (Some CER analyses report results according to Quality Adjusted Life Years).
  • And of course people interested in biopharma and medical device innovations are concerned that CER will be used not just to inform clinicians and patients, but to justify coverage and payment decisions which will impact R&D in therapeutic areas where reimbursement for innovative products is denied or limited.

All of these factors point towards larger issues of how to ensure that medical practice is maximizing knowledge to optimize clinical care for the good of the patient and society.  In some cases, this is termed Evidence Based Medicine (EBM).  In theory CER should support good EBM ASAP.  And from what President Obama has said, he wants this done PDQ.

Health System CER & Evidence-Based Interventions
While all these challenges for CER are ongoing, there also seems to be opportunities for applying the principles of CER and EBM to more system wide properties of the US healthcare system to increase value and efficiency.  For example - and I hope I’m not beating a too tired horse here - but the surgical checklist (and similar quality improving activities) have been shown to increase quality and reduce costly events, but not all hospitals and clinicians are using them.  Therefore, how about research to compare the effectiveness of hospitals (or surgeons, etc.) that use and don’t use such practices?  Some people might say that we don’t need this research since the value of these practices is already known, but perhaps focused research highlighting this information will serve as a big push to get the laggards on-board.

Similarly, CER type analyses could be applied to Medical Homes to determine what characteristics and capabilities of Medical Home medical practices make them better at improving the quality of patient care and controlling overall spending.  In particular, there might be specific features of Medical Homes that would be most important for diabetics, and others for patients with CHF, etc.  And currently NCQA’s 3 tiers of Medical Homes build upon each other, but don’t permit greater granularity nor do they distinguish between potentail patient populations. This research might be complicated, but with initiatives such as Medical Homes being proposed as a way to redesign and reconfigure outpatient care in the United States, more focused research beyond the existing and planned demonstrations and pilot projects might be very worthwhile expenditures.

P4P for Cost Containment
Another big push for cost containment in health reform is pay-for-performance (a.k.a. P4P).  While the knowledge gained from CER could certainly be fed into P4P practices, P4P itself has some controversy about how well it does or does not work to change behaviors to improve quality and reduce costs. At a breakout session about P4P at a conference on Friday led by Bob Galvin, MD (GE’s Director of Global Healthcare), I stated that two basic criteria that P4P interventions need to be successful are:

  1. The group effected needs to be small enough that each individual feels that changing their actions will effect their compensation, i.e., a group of 500 clinicians is too large, but it most likely can be larger than 5.
  2. The information about how the group or the individual is doing towards any P4P goals is delivered often enough to provide timely feedback, i.e. once a year is not frequent enough, perhaps quarterly is OK, and monthly would be great.

Dr. Galvin pointed out that the size of the P4P incentives also needs to be significant, i.e. it can’t max out at $100 per clinician.  And another participant noted that the P4P measures need to be controllable in some way by the clinician.  For example, while patients’ seat belt use might be somewhat influenced by clinicians’ reminders and admonishments, clinicians are much more able to see that their diabetic patients are getting regular HbA1C testing, eye exams, and appropriate immunizations.

Coming Full Circle From CER to P4P
18 years ago I coauthored a book chapter about the structure of bonus pools and other P4P-type incentives for physicians in nascent managed care organizations. Unfortunately, in the early 1990s, there weren’t robust information systems to provide data about “performance” for these P4P systems to be effectively implemented.  Perhaps now - and in the future - as health IT matures and become well integrated into healthcare delivery, better data will be available and P4P can be productive for clinicians, patients and society.

To help make that potential a more likely reality, perhaps some of the CER efforts could also be directed toward determining how to best structure and implement P4P programs to maximally change clinician (and possibly patient) behaviors to better utilize information about what is already known to work best in medical care.  And then these same P4P interventions would be in place and prepared to use the new knowledge that will come out of the expanded CER programs starting this year - and which will hopefully enable us to dramatically improve medical care and the medical system in the future.

Posted in Comparative Effectiveness, Delivery of Healthcare, Economics & Financing, Health System Reform | 1 Comment »

Quality, Checklists, Patient Education, the TV Show ER, and Comparative Effectiveness

By Michael D. Miller MD
March 16th, 2009

In case you missed it last week, amidst all the returning stars for one of the final episodes of the TV show ER, there was a dramatic Operating Room scene where Dr. Benton (played by Eric Lasalle) is “observing” the kidney transplant of Dr. John Carter (played by Noah Wyle), because as we see, the transplant surgeon is a very coarse and roughshod individual.  The significance of the scene is that as the surgery is about to begin, Dr. Benton pulls out his  pre-surgical checklist and browbeats the transplant surgeon into going through it - during which the nurses note their concern that they don’t have reperfusion solution in the OR, so they go and get some as the surgery starts.  Since this is TV, this turns out to be crucial when the kidney develops a clot, and a delay in getting the solution could have meant the difference between success and failure of the kidney transplant.  (Note - this connection may be taking a bit of artistic/entertainment license, but the point is that delays in having needed equipment or supplies can effect the quality of care.)

While Atul Gawande has written about such checklists in the New Yorker magazine, perhaps this fictional medical TV drama will help more people understand the importance of such quality improving steps, and even encourage them to start asking their doctors and hospitals if they use these types of quality improving checklists….. And if not, why not?

Physicians’ Perspectives
The next day I was talking with a physician friend, and mentioned the episode.  I was both bemused and concerned that he said all the staff is his outpatient clinic were talking about the returning stars, and nobody had mentioned the checklist scene.  We then talked about how physicians often think the way they do things is the best, yet generally lack any data to show how well they are really doing.  We agreed that physicians have traditionally viewed checklist etc,  as “cookbook” medicine that took away their autonomy.  I pointed out that while this might be true on a very microscopic level, by systematizing what they routinely do in a way that improves outcomes, they can then focus their knowledge and skill onto the unique aspects of each patient’s needs.

This is similar to what a basic science researcher once told me about golf. (He is a near scratch golfer.)  He told me that since the game has so many variables, more of them that you can eliminate the better you will perform.  For example, always playing with the same clubs is obvious, but for the same reason you should also play with the same brand and type of ball and glove, and develop standard pregame and preshot routines.  That way, you can focus on the variables you can’t control, such as the weather, the wind, the lie of the ball, etc.  The same is true for clinical care.  By standardizing the routine and repetitive actions according to protocols that have been shown to work well, clinicians can focus on what is variable and important.  (This is also why I always keep the same set of things in one pocket: keys, chapstick, two blue pens, one red pen, and my migraine medicine. And why I always leave my keys, wallet, sunglasses, etc. at same place at home.  That way I never have to spend time looking for things I use all the time.)

Collecting and analyzing data about individual physician performance is really going to be the next significant development in health reform and quality improvement.  And it is already occurring in some places - such as within the health benefits program for Massachusetts government employees.

This data collection, analysis and reporting will be similar to what is being done for hospitals, and thus will follow the trend of taking technologies out of the hospital and using them in the outpatient world.  However, as with all healthcare data analysis. the major challenge will be in adequately adjusting for patient differences so that physician performance is based upon realistically achievable outcomes rather than the severity of the patient’s underlying illnesses.  (The limits of such risk adjustment have hindered the usefulness of hospital quality data reporting.)

Comparative Effectiveness
The recent stimulus legislation included $1.1 billion for comparative effectiveness research.  Greater federal funding in this area has raised concerns among some people in the medical research industry because this research could focus on comparing one medicine to another, or a medicine to a device, etc. without adequate risk adjustment in the research - and then be used by insurance companies and government agencies to make coverage and payment decisions.  And these concerns are legitimate because using such analysis and research for coverage decisions about medicines and devices has been done in countries such as England and Australia.

However, there is also an opportunity for comparative effectiveness research to be used to improve actual clinical practices by developing a broader array of checklists and other standardized protocols.  This is part of the promise of electronic medical records, since they can easliy incorporate such standardized guidelines into their formatting.  But from what I can tell, each brand and type of EMR/EHR has different standardizations and guidelines, and the way they display them can cause clinicians to quickly suffer from “alert fatigue,” so that eventually clinicians ignore all the suggestions and warnings - making them worse then nothing.

Aside from the technical issues of EMRs, the systemic challenge for successfully using comparative effectiveness to improve clinical care in this way is overcoming the resistance and fear of physicians. This factor almost ended the existence of the federal Agency for Healthcare Quality and Research, because its first major project, (when it was called the Agency for Health Care Policy and Research), found that surgery for low back pain was generally not indicated.  This conclusion caused such a reaction in the medical community that Congress almost stopped funding the entire agency.

Conclusions

  • Innovations that are being used in hospitals will be increasingly used in outpatient clinics and private practices.
  • These innovations will not only be technologies, such as diagnostic tests, but also methods of care, such as standardized checklists and protocols.
  • Using comparative effectiveness research to develop and validate the ability of such standardization to improve outcomes, will have greater effects on increasing quality of care and controlling costs than will research comparing different treatment options for individual diseases - even for very common and costly conditions like diabetes and CHF.  This will be true because even if such research shows which treatments are best, if clinicians aren’t following these recommendations in standardized ways, the value of this knowledge for patients and the healthcare system will be dramatically diminished.
  • Including physicians, other clinicians, and other stakeholders in the development and implementation of standardized practices will be critically important for their successful adoption and use - because as was seen in the dramatization in the ER episode, big personalities of individuals can overshadow, subvert or sidestep the proper use of standardized practices so that they may be followed in substance, but ignored in spirit.

Posted in Delivery of Healthcare, Quality of Care & Safety | 2 Comments »

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