Evidence-Based Medicine Could Expand |
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Various industry insiders were interviewed for this report. They examine the current healthcare debate taking place. You can read the raw interviews by visiting the Healthcare Reform section. Check out the online healthcare reform debate book as well.
Many proponents think it can.
"Absolutely," says Dr. Gregory H. Dorn, executive vice president and chief operating officer, Zynx Health. "Studies have shown that large populations of patients receive sub-optimal care due to errors of underuse, misuse and overuse of interventions. A great advantage to patients is that they would be confident that they are receiving a national standard quality care regardless of the region in which they live or the healthcare provider that treats them."
For the Pap smear, the recommendation from the American College of Obstetrics and Gynecology changed to an initial cervical cancer screening at age 21, and rescreening less frequently … from annually to once every two years.
This will result "in a significant decrease in the number of women who have Pap smears each year … which, in turn, will save on healthcare costs without affecting outcomes," says Dr. Allen Weiss, president and CEO, Naples, FL, Community Hospital.
For breast cancer screening, the U.S. Preventive Services Task Forces recommended last year against routine mammograms for women in their 40s, and urged reducing to biennial starting at age 50 for those needing them. Of course this, too, would mean fewer costly mammograms being given.
Evidence-based medicine simply means adhering to the best available and most proven clinical guidance on procedures such as these two, and then standardizing the treatment protocols for medical offices across the country.
These cases "support the main principle behind the need for evidence-based healthcare solutions: because clinical evidence is always changing, evidence-based findings should be continually evaluated," says Dr. Dorn. "Patient safety and quality can be compromised if a static approach to EBM is pursued. One-time development and implementation efforts go out of date quickly."
EBM might also save costs, not to mention saving doctors, by thwarting malpractice lawsuits.
Yet there are drawbacks to this approach as well ... namely, how many patient cases don't fit neatly into the protocols. We'll examine the pros and cons and various factors.
The Basics "The pros of it are simply where evidence exists that a specific medical protocol yields a positive result, it makes sense to follow that protocol until something is proven to be more effective," says Matt Modleski, vice president of Stovall Grainger Modleski, Inc., health care consultants.
"The easiest place to see how this works well is when you have a throat culture that comes up positive for strep. The evidence says an antibiotic should be prescribed to kill the infection. This is an easy example and one that many people have experienced."
To Dr. Margaret Lewin, medical director of Cinergy Health, "the pros are that these decisions are statistically most likely to achieve the desired clinical result given the current state of knowledge. ... This is an important concept which, if fully implemented, could lead to better outcomes and lower costs."
Specifically, Dr. Weiss believes EBM "would allow more predictable results for patients because the current 40 percent variation in treatment for the same diagnosis would be reduced to near zero. For example, only 59 percent of Medicare patients with cancer receive "best practices," according to the National Quality Forum, while only 55 percent of all U.S. patients receive recommended care according to RAND Corp.
"Patients do not receive recommended care as prescribed in national medical specialty guidelines about 46 percent of the time. Another 11 percent of patients received care that is not recommended and potentially harmful.
"Quality of care varies considerably by medical condition. People with cataracts receive about 79 percent of recommended care. Patients with alcohol dependence receive only about 11 percent of recommended care. People with diabetes receive only 45 percent of the care they need. Fewer than half of patients with diabetes have their blood sugar levels measured on a regular basis. Thirty-two percent of patients with coronary heart disease get recommended care, and only 45 percent of patients who suffer a heart attack receive medications that could reduce their risk of death by more than 20 percent. This information is gleaned from Health Leaders Oct 2009."
Specifically for lowering costs, Modleski notes that "another benefit of EBM is that as diagnoses become more and more precise, we can and should use lower cost providers to deliver the care that the evidence suggests. This is a very contentious issue where 'fee-for-service' medicine is practiced because every patient who sees a lower cost provider takes money from the higher cost provider further upstream. Closed systems like Kaiser and Intermountain Health have worked to align incentives to make that lower cost provider the best choice when a diagnosis is precise enough to permit it."
How EBM Works Dr. Susan Lawrence, founder and executive director of the Catalyst Foundation, says her patient care/supportive services are "informed by the findings of the Adverse Childhood Experiences (ACE) Study (please see www.acestudy.org and www.cdc.gov/nccdphp/ACE/).
This study, conducted by the Centers for Disease Control and Kaiser Permanente, "provides irrefutable scientific evidence that childhood abuse and trauma is the root cause of the leading causes of death in this country."
She says "as it is currently practiced, primary care medicine treats the tertiary effects of childhood abuse and trauma, such as diabetes, heart disease, morbid obesity and stroke. At Catalyst, all patients/supportive service clients are screened for ACE factors, which are then compassionately and supportively discussed by our trained staff; referrals are then made to Catalyst’s on-site programs to assist them in addressing the ongoing effects of childhood abuse on their current health and well-being. In this way, Catalyst practices primary prevention in addition to providing necessary tertiary care."
At Naples Community Hospital, "we have over 150 clinical pathways which incorporate EBM," Dr. Weiss reports. "Many of these pathways are embedded in our electronic order system, which is used currently over 50 percent of the time. We anticipate the majority of orders placed in the next year to be electronic and evidence based."
Big Impact on the U.S.?
Dr. Lewin: "Medical problems could be solved more efficiently and effectively, leading to better clinical outcomes." Dr. Weiss: "Most experts agree there is currently 30 percent waste in the system due to misuse, overuse, underuse, defensive medicine, fraud, abuse and miscommunication. Additionally, there is an opportunity to make the malpractice system more efficient. EBM would have an immediate positive impact on all of these unfortunate processes." Dr. Lawrence: "There is also an enormous cost-saving aspect. According to Dr. Vincent Felitti, co-principal investigator of the ACE Study, doctor office visits decreased by 35 percent in the year following the implementation of an ACE Study-based system of care at Kaiser Permanente in San Diego. This was attributed to a decrease in the level of anxiety of many patients (and visits for anxiety-related physical symptoms), who were able to share, in a safe and supportive environment, things they felt they would take to their grave."
Dr. Dorn: "When coupled with an effective workflow delivery format and a robust measurement approach for assessing results, evidence-based medicine can have immense impacts on the quality, safety and efficiency of patient care."
The Malpractice Factor Dr. Kathy McReynolds, a bio-ethicist with the Christian Institute on Disability, notes that "evidence-based medicine is supposed to provide more efficient, quality care, lowering medical errors and saving lives. This should, in turn, lower the risk of malpractice."
Dr. Weiss tells us that according to a study in the Quarterly Journal of Economics, "the malpractice system includes approximately 1 percent of direct costs (awards, legal fees, administration, etc.) and 9 percent for the indirect costs of so-called 'defensive medicine.' Of the 1 percent which goes to direct costs, the harmed patient only gets less than half.
"EBM would help define what was and was not malpractice. If EBM was followed correctly and there was a bad outcome, that would be unfortunate but not malpractice. If EBM was not followed and there was a bad outcome, then malpractice was committed. This would simplify the system ... saving 0.5 percent direct costs ... but more importantly the 9.0 percent cost for defensive medicine would also be eliminated."
Dr. Lewin: "If a medical decision is based on such evidence, one would hope that even bad outcomes could not be attributed to malpractice by the practitioner." If the doctor deviates from the EBM protocol, that could lead "to the risk of malpractice action should the outcome be unfavorable."
Dr. Lawrence: "I would say that utilizing evidence-based medicine, in any form, should provide some protection for healthcare providers if they are sued."
Dr. Dorn: "What I’m seeing is that clinicians are held accountable to the standard of care, regardless of whether they know the standard. In effect, the standard of care becomes the 'law' that clinicians are to follow. Evidence-based medicine establishes this standard of care, and adds transparency by incorporating the standard into practice, enabling clinicians to be aligned with it."
Modleski: "Where precise diagnoses exist and the providers know about them, most would tell you they feel compelled to follow the guidelines for two reasons. The first is to avoid being sued, the second is to facilitate getting paid.
"For example, oncologists today who embark on an 'I’m going to do it my way' mentality may find themselves unable to recover the cost of very expensive chemotherapy drugs to the tune of tens of thousands of dollars. Providers will also tell you that evidence-based guidelines increase their 'hassle factor' immensely as the insurers require the provider to chart the reason they’re not following the established guidelines even if clinically they have a legitimate reason not to follow it."
Drawbacks and Difficulties
For starters, here are a few from Dr. Lewin:
"-- There are only a limited number of clinical trials whose outcomes are conclusive enough to answer the enormous number of clinical questions.
"-- Controlled clinical trials are expensive and usually take years to reach their conclusion; even then, they usually require confirmation by other trials.
"-- Medical science continues to advance at such a pace that clinical trials cannot keep up with the questions raised.
"-- It is likely that many treatment options not proven by evidence-based medicine will be rationed (i.e., they will not be reimbursed by public or private insurance)."
For patients, Dr. McReynolds points out that many people feel evidence-based care "is limited at best because human beings differ in many ways biologically. Some diseases involve multiple organs and not all patients respond to treatment in the same way. The fear is that it will discourage health care providers from considering a wide array of treatment options."
Modleski: "EBM works well when the diagnosis is precise. It does not work well when tried in an environment of non-precision or what we’ll call 'intuitive medicine.' Even when it’s been established that a diagnosis is precise enough to follow established guidelines, here are just a few of the challenges to more fully implementing EBM: How fast will evidence change, who will establish the protocols and who will pay for the clinical trials? Who will say what level of evidence requires a switch to a new protocol? These are just a few of the 'devils in the details' components of switching to a care delivery system that relies more on evidence than what we use today."
Can these disadvantages be dealt with? Dr. Weiss thinks so: "In the past many, physicians viewed EBM as 'cookbook' ... saying that each patient was unique and therefore needed a unique treatment. Certainly there are significant differences among patients but there are many more similarities. EBM would eliminate waste and ineffective treatments."
Dr. Dorn notes that some people "perceive evidence-based medicine as routinized care that compromises the art of care, or that doesn’t weigh in on most clinical practices; however, the broad application and benefits of evidence-based medicine have now been widely documented in the literature, dispelling these concerns."
Dr. McReynolds says supporters of evidence-based medicine believe it "will not limit treatment plans, but will actually give a wider range of treatment options that have proved to provide better quality outcomes in a variety of clinical settings."
To Matt Modleski, "the real challenge in maximizing the uptake of EBM will be designing a more strategic care delivery model that realizes EBM only works in 'precision' medicine and not expecting it in the areas of 'intuitive' medicine."
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The protocol U-turns ... much in the news recently ... on Pap smears and mammograms focused attention on the mundane concept of evidence-based medicine (EBM) ... and whether it can dramatically improve the quality of healthcare in the U.S. while lowering costs.