Evidence Based Medicine: A Consumer Health Issue
DRAFT (originally presented as an AAHE poster session at AAHPERD, April 2006)
There are many issues that confront health educators as they prepare to assist their students to achieve health literacy. Students are expected to access information, products and services to enhance health1. Among the most important health related issues that consumers need to understand surrounds the selection of appropriate health care. Consumers utilize health care services through their personal health insurance system or through government supported programs. Increasingly, the health care system is being asked to adopt methods and practices that are evidence based. An understanding of evidence-based medicine is essential for both consumers and health educators if individuals are to be trained to assess the validity of many health care methods.
What is Evidence Based Medicine?
Evidence based medicine is a contemporary philosophy and scientific practice that advocates using scientifically proven techniques, devices, materials and medications within the practices of health care. It is an approach that argues that it isn’t enough to know the efficacy of a particular medical treatment or practice; whether it ought to work, makes sense to utilize, or is common practice. Instead, evidence based medicine asks whether a particular treatment, practice or procedure actually extends or improves the quality of life and what if any are the risks2. Most definitions used by the medical community include three components in a description of evidence-based medicine: scientific evidence, physician judgment, and patient values3.
Scientific evidence most commonly refers to the results of studies that follow accepted scientific procedures, the randomized controlled treatment approach (RCT). The RCT is widely considered the “gold standard” for selecting evidence-based procedures because the evidence was collected from randomized, controlled, double-blind studies that used a large sample size and were published in a scientific journal. Unpublished research, particularly if it comes directly from a vendor is usually not considered due to potential bias, and a tendency to report lower treatment effects than published studies. 16
A tradition in medicine has been that the role of the individual physician is to interpret research and other widely accepted practices and apply them correctly to individual patients. Because the average practitioner is extremely busy, it would be impossible to review every published study. Medical and health practitioners must however remain abreast of current research in their field and make treatment decisions based upon their professional knowledge and experience as it relates to each individual patient’s needs and wants. The difficulty is knowing when and how to apply the collected evidence into the real world of clinical practices. 8
Patient Values refers to those aspects of a healthy life that a person places at their highest priority, such as maintaining a healthy lifestyle through exercise and proper nutrition, or being diligent in scheduling screening exams as appropriate. These health related choices may be influenced by cultural or religious beliefs, the individuals economic situation, or their habits or practices. When weighing the benefits of an evidence based approach to medical treatment, the patient will bring with them their personal preferences about how they wish to receive care based upon their values about how that treatment affects their life choices.
Traditional medicine has always drawn upon research, case studies, anecdotal stories, and personal experience of the physician. Evidence based medicine is a more structured process that sets a standard for whether a chosen practice or treatment actually demonstrates effectiveness. 7 Effectiveness is measured by three standards. The first standard examines the quality, strength and consistency of the scientific evidence about the procedures efficacy. Second, the standard examines the applicability of the evidence or evidence about effectiveness when the practice is utilized. And third, the results of this standard show either superior, safer, or a use preference in direct comparison to alternative treatments4.
Arguments against Evidence Based Medicine
Prior to this new revolution of evidence based medicine, much of the decision making in medicine was based upon the individual experience of the clinician and the long standing traditions, practices, and biases of the medical community. These practices came from years of medical usage and where learned by medical practitioners while they were students and reinforced by colleagues throughout their careers. Evidence based medicine, in some cases, asks experienced medical personnel to abandon accepted and successful ways of practicing due to the scientific evidence being presented.
Debate continues about the usefulness of randomized controlled treatment (RCT) in health care settings due to the fact that many diseases or illnesses do not follow a simple linear cause and effect relationship. There is frequent and sustained criticism of evidenced based medicine due to it’s perceived over reliance on randomized trials.15 Since randomized controlled trials began with studies in agriculture, it may be questionable whether procedures intended to determine optimal growing conditions for plants might not be readily applicable to complex human problems such as mental health issues. 5 To alleviate these types of concerns, both U.S. based and internationally based research groups have established centers to collect and document evidence showing which health care practices work and which ones do not work effectively. 6
For the consumer, patient or medical practitioner the decision to utilize a specific treatment or procedure must be based upon the evidence presented in support of that action.
How Can Evidence Based Medicine Affect the Consumer?
A great dilemma that health consumers face today is to understand that their behavior affects the rising cost of health care. There is a widely held belief that new technology in medicine, whether equipment or drug, is automatically better then any existing form of treatment9. This fallacy is described as, “post hoc ergo proctor hoc.” This Latin term means, “after this therefore because of this.” For example, I took the new drug and I got better therefore it must have been the new drug. This obviously ignores any possibility of multifactor causes of the treatment.
The media often reports that a specific factor is directly the cause of a certain illness or disease. Science knows that there are multiple risks with any medical condition. There is no general understanding of the epidemiological definition of risk. That is, the probability or chance that an individual will develop an illness, disease, or condition over a specified period of time.14
The implication from evidenced based medicine for the educator and consumer is that medical and health related decisions which are made as a result of evidence presented may narrow the choices that a patient/consumer has in their total health care package. If indeed an evidence based practice is more effective then another, the best health decision would be to follow those guidelines. If, however, a patient/consumer wishes to choose the more costly or risky protocol (the product identification) then a strict evidence based approach would not allow this option for the individual.
What can the Consumer/Educator Do?
In information prepared by the Association of Health Care Journalists,10 there is a guide to help evaluate medical reporting to ascertain whether the information presented is accurate and scientifically based. This guide can serve as a focus for the types of questions both health educators and their students need to learn to ask as consumers of health care.
· What is the size of the potential benefit offered by the therapy, and for what types of patients is it beneficial?
o When an individual evaluates a potential treatment or therapy, they should ask to what degree does the treatment work effectively and does it work with the same effectiveness for everyone? If a patient takes a particular drug, for example, their risk might be cut from 2 percent to one percent risk. While this is a “50%” reduction of risk it is not very significant in a real sense and probably offers little protection in the long term.
· What are the potential harms associated with the therapy?
o All pharmaceuticals and many medical treatments can have some potential side effects. Most of the time these do not produce serious complications in users. But the informed consumer needs to ask about their personal risk associated with these potential effects.
· What are the links between your sources of information about the therapy and those promoting it?
o The informed consumer needs to be aware that many medical researchers and practitioners have ties to the manufacturers of medical devices and drugs. Sometimes these links sponsor research, provide travel, or support consultancy. There is contention that this sponsored relationship only reports results that show a favorable outcome. The consumer should therefore exercise caution when deciding the efficacy of the proposed treatment where potential bias may exist.
· How strong is the evidence to support the claims being made about the therapy, and how does it relate to other available evidence?
o The “gold standard” for demonstrating the strength of research evidence is the use of randomized, controlled treatment (RCT). Evidenced based medicine relies on the strength of evidence based upon RCT studies. While it is acknowledged that there is likely publication bias (a tendency to report findings based upon strength and direction),11 a randomized, controlled treatment study has the best likelihood of demonstrating the effectiveness of a particular device, drug or practice, at least with the group of subjects used within the studies. Currently, there are designated centers distributing information on a growing collection of evidence based research pertaining to a number of diseases and conditions.12 Accessing the information will help the consumer make informed choices.
· What is the natural history of the condition for which the therapy is being offered, and is there potential for what some have called "disease mongering"?
o “Disease mongering can include turning ordinary ailments into medical problems, seeing mild symptoms as serious, treating personal problems as medical, seeing risks as diseases, and framing prevalence estimates to maximize potential markets.”13 In this very health conscientious society, advertising constantly highlights a vast array of medical conditions for which we are supposedly susceptible. Some experts question whether it’s the drug investors who are seeking to blur the lines of real physiological illness and media induced illness. 17 The well informed consumer can appraise their health condition and make a judgment about whether they need treatment or whether it will pass on its own.
· What are the alternatives to the therapy being offered (e.g., no action or watchful waiting, generic drugs, non-drug options, complementary therapies)?
o Our society places a lot of faith in the ability of our medical system to solve our health problems. Most people are readily willing to accept the advice of their health care provider to take a drug, have a procedure, etc. However, there are multiple alternatives to this traditional view of medical care. Although an evidenced based approach questions the proven effectiveness of some complementary and alternative forms of medicine (CAM), these are choices for the consumer.
· What are the costs of the therapy and are the potential benefits worth the cost?
Cost of the drug, device or procedure
LOW HIGH
LOW low cost/low effectiveness high cost/low effectiveness
Effectiveness of the Drug,
Device, or Procedure
HIGH low cost/high effectiveness hiigh cost/high effectiveness
If you examine the preceding table you will note that making choices about receiving health related care requires that the consumer consider the cost and the effectiveness of any health care choice. Most people will select a highly effective drug, device or procedure regardless of the cost. Their main concern is returning to full health.
MORE COMING HERE
References
1. Health Standards
2. Hope or Hype
3. Scalise
4. Helfand, EPC (PEBB Presentation)
5. Brown et. Al. RBR
6. Atkins, et. al in Supplement. “better Information
7. Baum, Neil Urology times
8. Green Gold AHA
9. Deyo, Personal Communication
10. Tipsheet—For Reporting on Drugs, Devices and Medical Technologies, Ray Moynihan, The Commonwealth Fund, September 2004
11. Shekelle, et. al. AIM 2005
12. Atkins et.al. AIM 2005
13. Ray Moynihan, journalist a, Iona Heath, general practitioner b, David Henry, professor of clinical pharmacology c. http://www.vaccinationnews.com/DailyNews/April2002/SellingSickness.htm retrieved July 22, 2005
14. Friis and Sellers
15. Santaguida, et. al AIM 2005
16. Chou and Helfand, AIM 2005
17. Cassels and Moynahan, Selling Sickness – How drug companies are turning us all into patients. Avalon Publishing Group, 2005