I believe evidence based medicine is the backbone of modern healthcare.
But like so many important and exquisite things, evidence based practice is fragile and easily damaged. What’s even more worrying is the fact that it can, and has been, misapplied and used fraudulently.
A lot has been written recently about the pros and cons of evidence based practice, its strengths and its weaknesses. Many questions have been asked.
Who decides which research issues should be addressed and what studies should be performed? How is evidence gathered and how are the results implemented into clinical practice? How do we deal with conflict of interest? Is the pharmaceutical and medical devices industry in control of the ship? Do they set the research agenda? Can evidence based medicine tackle all the needs of our patients?
So, if evidence based medicine needs an overhaul, how should it be done and who should do it?
Or, if evidence based medicine can’t be trusted, should we lay it aside? Can’t we just rely on good clinical judgment and experience like we used to do. Science is useless anyway, if not used properly.
Are there other alternatives? Does broken and ruined evidence based medicine open the door for alternative or integrative medicine?
Tim Minchin addresses some of these issues wonderfully in his beat poem Storm, which centres on Minchin having an argument with a girl named Storm, who believes in various, more spiritual alternatives in lieu of evidence based medicine.
Read on, and I’ll tell you more about it.
What Is Evidence Based Practice?
Evidence based medicine started gaining ground almost 30 years ago. The concept soon spread to other fields such as dentistry, education, psychology and nursing, and came to be known as evidence based practice.
Evidence based practice relies on the use of evidence from well-designed research in clinical decision-making.
However, evidence based practice does not imply that individual clinical expertise and experience should be abandoned. In fact, it means integrating scientific evidence, most often based on clinical trials and systematic reviews with individual expertise acquired through clinical experience and clinical practice (3).
Randomized clinical trials and systematic reviews play a key role for evidence based practice.
A systematic review is a review of the scientific literature aimed at a certain question in order to identify and analyze scientific evidence relevant to that issue. A systematic review addresses a clearly formulated question; for example: Do statin drugs improve survival following a heart attack?, Does regular exercise reduce the risk of stroke?, or Does regular intake of Vitamin D reduce the risk of cancer?
All the existing primary research on a topic that meets certain criteria is searched for and collated, and then assessed using stringent guidelines, to establish whether or not there is conclusive evidence about a specific treatment (4).
The Cochrane Collaboration is an example of a large group of specialists who systematically review randomized trials to facilitate the choices that medical practitioners, consumers, policy-makers and others face in health care (5). The aim is to know if one treatment works better than another, or if it will do more harm than good.
Medicine and Alternative Medicine
The definition of evidence based practice highlights the difference between medicine and alternative medicine.
Alternative medicine is often defined as any practice that is put forward as having the healing effects of medicine, but is not based on scientific evidence (6). It consists of a wide variety of practices and therapies such as homeopathy, chiropractic and acupuncture to name a few.
In Tim Minchin’s elegant poem, the beautiful Storm expresses her admiration for alternative medicine.
Why take drugs
When herbs can solve it?
Why use chemicals
When homeopathic solvents
Can resolve it?
It’s time we all return-to-live
With natural medical alternatives.
But, what if a scientific study proofs that the homeopathic solvent is effective? Then, according to the above definition, the method can not any longer be defined as alternative medicine. Minchin describes this beautifully in his poem when he responds to Storm.
By definition, I begin
Alternative Medicine, I continue
Has either not been proved to work,
Or been proved not to work.
You know what they call alternative medicine
That’s been proved to work?
So if a homeopathic solvent is proofed to work, it’s no longer homeopathy. It’s evidence based medicine.
What About Integrative Medicine?
Integrative medicine attempts to combine alternative medicine with evidence based medicine. It focuses on wellness and health and treating the entire person rather than treating a disease. It puts a strong emphasis on the patient-physician relationship (7).
One of the weaknesses of evidence based medicine is that it usually addresses specific symptoms and diseases, or analyzes specific effects of certain treatments. Thereby, it often fails to deal with the subtle integration of body, mind and spirit which may be very important for the well-being of the patient.
On the other hand, the weakness of integrative medicine is the fact that it relies on methods that have not been proven by scientific methods to be effective.
However, if a patient suffering from cancer believes his quality of life is improved by yoga, massage, biofeedback, tai chi meditation, or other stress reducing techniques, shouldn’t such services be available in our health care system, although scientific evidence for efficacy is lacking?
Today, many hospitals in the US are offering an integrative approach to healthcare. The Duke Center for Integrative Medicine is a classic example (8).
Is Modern Medicine Always Evidence Based?
The purpose of clinical practice guidelines is to provide recommendations on care of patients. Access to these guidelines enables medical professionals to more easily practice evidence based medicine.
For more than 25 years, the American College of Cardiology (ACC) and the American Heart Association (AHA) have published guidelines in different areas of cardiology.
The strength of evidence is assessed by a specific grading system which, in fact, is quite simple. It combines a description of the existence and types of studies supporting a certain recommendation.
Level of evidence A: recommendation based on evidence from multiple randomized trials or meta-analyses
Level of evidence B: recommendation based on evidence from a single randomized trial or non-randomized studies
Level of evidence C: recommendation based on expert opinion, case studies, or standards of care.
In 2009, a very interesting paper (9) was published in the Journal of the American Medical Association (JAMA), assessing the strength of evidence underlying the ACC and AHA practice guidelines.
In other words, how much of the recommendations provided is based on strong evidence (level A), and how much is based only on expert opinion, case studies and standards of care?
It turned out that the median level of evidence A recommendations was only 11 percent across guidelines. Interestingly, most of the current guidelines included more than 50% level of evidence C recommendations.
The authors correctly concluded that “expert opinion remains a dominant driver of clinical practice, particularly in certain topic areas, highlighting the need for clinical research in these fields”.
So, if cardiologists follow clinical guidelines, which I believe most of us do, only about 11 percent of what we do can be considered evidence based practice. What should we call the other 90 percent?
Evidence Based Practice – Should It Be Rescued?
In a recent paper published in The BMJ (2), Trish Greenhalgh and colleagues highlight some of the problems faced by evidence based practice today.
One of the biggest problems is that the drug and medical devices industry often sets the agenda.
They (the drug and medical devices industry) define what counts as disease (for example female sexual arousal disorder, treatable with sildenafil and male baldness, treatable with finasteride) and predisease “risk states” (such as low bone density, treatable with alendronat). They also decide which tests and treatments will be compared in empirical studies and choose (often surrogate) outcome measures for establishing efficacy.
Greenhalgh also points out that he volume of evidence has become huge and sometimes unmanageable for practicing clinicians.
Furthermore, statistically significant benefits observed in clinical trials may be marginal in clinical practice.
The 74 year old who is put on a high dose statin because the clinician applies a fragment of a guideline uncritically and who, as a result, develops muscle pains that interfere with her hobbies and ability to exercise, is a good example of evidence based medicine wagging the clinical dog.
Greenhalgh also addresses how the overemphasis on following algorithmic rules may become problematic in clinical practice.
Finally, she points out that the design of clinical studies often makes it difficult to tackle patients with multiple conditions. Evidence based management of one disease may affect other disease conditions in an unpredictable manner.
However, scientists, clinicians and policy makers have to take control. If the drug and medical devices industry continue to control the ship, evidence based medicine will never be what we dreamt it could be.
Fraudulent use of scientific methods has to be taken very seriously. However, as in other areas of life it will be very difficult to erase completely.
It’s clear that evidence based medicine can’t be salvaged if scientific research methods are not used honestly and correctly. In this respect, the responsibility of peer reviewed journals is huge. It’s up to them to set the standards.
Guideline writers should acknowledge the lack of evidence for most recommendations and write shorter guidelines. They should stick to hard evidence. Who needs hundred pages of expert consensus?
Furthermore, although I believe that evidence based medicine should lay the groundwork for how we practice medicine, we should be allowed to incorporate other methods as long as they don’t harm our patients, and if the patient believes that they are helpful. In fact, I believe shared decision making can play a key role here.
We must learn to attend to all the needs of our patients and not look only at specific symptoms or diseases. This will imply that our research agenda, and our practice must become broader and more integrative.
Let me conclude with this part of Minchin’s response to Storm
I am a tiny significant lump of carbon.
I have one life and it is short
But thanks to recent scientific advances
I get to live twice as long
As my great great great great uncleses and auntses.
Twice as long to live this life of mine
Twice as long to love this wife of mine
Twice as many years of friends and wine
Of sharing curries and getting shitty
With good-looking hippies
With fairies on their spines
And butterflies on their titties.