Comparative Effectiveness Research and the Medical Home -- Made for Each Other?

Robert M. Centor, MD; Melissa Clarke, MD; Robert W. Donnell, MD; Alicia Hart, MD; Brian Haynes, MD, PhD, MACP; Desiree Lie, MD, MSEd; Roy M. Poses, MD

Disclosures

September 23, 2009

Roundtable Question From Medscape Editor

At a July meeting of stakeholders involved in encouraging and implementing efforts to institute the patient-centered medical home, Carolyn Clancy, the Agency for Healthcare Research and Quality (AHRQ) director, stated that the medical home would not be able to exist without comparative effectiveness research (CER). Any comments?

Response From Participants

Desiree Lie, MD, MSEd

The term "comparative effectiveness research" is being bandied around as part of the healthcare reform and stimulus funding incentive. However, I think the concept also extends to systems interventions. Therefore, the following types of studies would fall under the definition of CER:

  • A study comparing one diabetic medication with another for glycated hemoglobin (HbA1c), end-organ damage, and quality-of-life outcomes;

  • A study comparing use of primary care solo physician practice vs a specialized diabetes education team for management of complicated diabetes with comorbidities, with quality-of-life outcomes, dollars saved, and hospitalization rates; and

  • A study that identifies areas (eg, by geocoding) with significant disparities in diabetes care (associated with race, access, etc), and then introduces a quality improvement intervention, such as provider education, to reduce the disparity with a quality outcome measure, and compares the outcomes with other areas without these disparities.

If this is the broad definition, then CER is clearly part of a patient-centered medical home concept to identify the best strategies to achieve the best outcomes.

Melissa Clarke, MD

Great description, Desiree. I would just add that in order to move to a cost-effective care model, you have to know what treatments/interventions are the most effective and at what cost. In this way, in a national model of care reimbursement, decisions can be made about what treatments will be preferentially reimbursed. One example is epoetin vs darbepoetin; both stimulate erythropoiesis effectively, but epoetin can be as much as 50% less expensive than darbepoetin.

The National Institute for Health and Clinical Excellence (NICE) in the United Kingdom is a model that has been looked at for conducting CER and making guiding policy on reimbursement. NICE issues 3 types of guidance:

  • Appraisals on technologies, medicines, medical devices, diagnostic techniques, surgical procedures, and health promotion activities;

  • Clinical guidelines for the appropriate treatment and care of people with specific diseases and conditions; and

  • Recommendations on the safety and efficacy of interventional procedures.

Primary care physicians in a patient-centered medical home model would be expected to use guidance from CER to choose cost-effective treatments, and make timely referrals and otherwise "quarterback" care for their patients using these recommendations as a playbook. From Dr. Clancy's comments, it seems as if AHRQ has been chosen to administer funds for conducting much of this ongoing research.

Alicia Hart, MD

My question in all of this: Aren't we oversimplifying medicine? Not everything that is "research" based is going to work in every population. I worry that our government is trying to boil healthcare and quality medicine down to a Burger King-like menu. Obviously, the start of quality healthcare is a medical home and the physician and patient establishing what works vs patients showing up in my emergency department looking for primary care or a second opinion. Why did we have to make medicine so complicated? Does it take an expensive research project to figure out the obvious -- that patients just need compassionate and competent care?

Brian Haynes, MD, PhD, MACP

It seems as if what we've been getting all along are burgers, without warnings and often in very expensive wrappings. It's time to add information about calories and constituents to the wrappings and provide cost-effective options that won't corrode our arteries while emptying our pocketbooks. Here's some fuel for this effort. A brief summary of the Institute of Medicine's Clinical Effectiveness Research Report has just been published in the Annals of Internal Medicine.[1] It defines CER as "the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat and monitor a clinical condition, or to improve the delivery of care." It also indicates: "The purpose of CER is to assist consumers, clinicians, purchasers, and policy makers to make informed decisions that will improve health care at both the individual and population levels." The American Recovery and Reinvestment Act includes a $1.1 billion "down payment" on CER. Although it may be an oversimplification to think of healthcare as being "evidence based" at present, particularly given the limits of current research, it seems to me that this is a big step forward in stimulating the generation of the types of evidence that are needed to make it so.

Roy M. Poses, MD

For what it's worth, here's the 2-paragraph explanation of CER that I have used on our blog:

Physicians spend a lot of time trying to figure out the best treatments for particular patients' problems. Doing so is often hard. In many situations, there are many plausible treatments, but the trick is picking the one most likely to do the most good and least harm for a particular patient. Ideally, this is where evidence based medicine (EBM) comes in. But the biggest problem with using the EBM approach is that often the best available evidence does not help much. In particular, for many clinical problems, and for many sorts of patients, no one has ever done a good quality study that compares the plausible treatments for those problems and those patients. When the only studies done compare individual treatments to placebos, and when even those were restricted to narrow patient populations -- unlike those patient usually seen in daily practice -- physicians are left juggling oranges, tomatoes, and carburetors.

Comparative effectiveness studies are simply studies that compare plausible treatments that could be used for patients with particular problems, and which are designed to be generalizable to the sorts of patients usually seen in practice. As a physician, I welcome such studies, because they may provide very useful information that could help me select the optimal treatments for individual patients.

For example, see this post: http://hcrenewal.blogspot.com/2009/02/attack-on-government-funded-comparative.html

Robert W. Donnell, MD

I believe that we will always need more CER because we will always need many types of research, but:

  • Those who claim that physicians don't have research evidence with which to compare treatments are either misinformed or disingenuous, because we have had a great deal of CER through the years. In a recent blog post, I listed 37 CER studies and linked to the Cochrane Collaboration, where there are countless more. (Here's the link to the blog: http://doctorrw.blogspot.com/2009/02/who-says-we-dont-have-comparative.html)

  • There is a strong economic and political agenda behind the current CER push, and that warrants skepticism.

  • The claim that there is political and corporate opposition to CER is a straw man. Although there is much opposition to the political agenda behind CER, I have yet to see serious opposition to the pure notion of CER.

  • CER affords unique opportunity for rigged design. I gave examples in a recent blog post at: http://doctorrw.blogspot.com/2009/04/comparative-effectiveness-research-and.html

  • The notion that government funding and control will make research more ethical and less biased is faulty. All you need to do is look at the National Center for Complementary and Alternative Medicine (NCCAM), a subsidiary of the National Institutes of Health (NIH), for an example of a research program riddled with bias, conflicts of interest, and ethical breaches -- not to mention tremendous waste.

Robert M. Centor, MD

I am very much in favor of individualized medicine; however, I strongly favor CER. During my career of over 30 years, I have seen new drugs come and go. Every new drug, and especially a new drug class, brings hope of significant improvement for patients. Too often we only hear and see hype and not data comparing new drugs with standard therapies.

Each day we have decisions to make on appropriate testing and therapeutics. We need comparative data in order to put testing and therapeutics into perspective.

Cost does matter. We do not have unlimited resources. As one medical blogger states repeatedly, we currently have covert rationing. I favor overt rationing as being more ethical and moral. We should understand the price for small increases in effectiveness.

We all make these decisions implicitly. I have refused to ever prescribe esomeprazole (Nexium®), because I believe that the company is unethical, and I do not believe that the drug has an advantage over less expensive proton-pump inhibitors.

When discharging uninsured patients, I find "Walmart" drugs that are good enough, because that is all the patient can afford. I would like to know whether simvastatin is as good as atorvastatin for most patients.

Should we invest in physical therapy for conditions? When does a positron emission tomographic (PET) scan really change our treatment plan? Why do so many patients with stroke have both a computed tomographic (CT) scan and magnetic resonance imaging (MRI)?

How long should we continue clopidogrel after stenting? How much benefit do we get for how much risk from lowering the HbA1c from 7.5 to 6.9 -- and at what cost? The same question works for a blood pressure range from 140/90 to > 130/80.

We have too many guidelines and too little wisdom. We need well-founded research to bring wisdom back to medicine.

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as:

processing....