by Trisha Greenhalgh, Jeremy Howick, Neal Maskrey, for the Evidence Based Medicine Renaissance GroupBritish Medical Journal. 2014 348:g3725It is more than 20 years since the evidence based medicine working group announced a “new paradigm” for teaching and practising clinical medicine. Tradition, anecdote, and theoretical reasoning from basic sciences would be replaced by evidence from high quality randomised controlled trials and observational studies, in combination with clinical expertise and the needs and wishes of patients. Evidence based medicine quickly became an energetic intellectual community committed to making clinical practice more scientific and empirically grounded and thereby achieving safer, more consistent, and more cost effective care. Achievements included establishing the Cochrane Collaboration to collate and summarise evidence from clinical trials; setting methodological and publication standards for primary and secondary research; building national and international infrastructures for developing and updating clinical practice guidelines; developing resources and courses for teaching critical appraisal; and building the knowledge base for implementation and knowledge translation.
From the outset, critics were concerned that the emphasis on experimental evidence could devalue basic sciences and the tacit knowledge that accumulates with clinical experience; they also questioned whether findings from average results in clinical studies could inform decisions about real patients, who seldom fit the textbook description of disease and differ from those included in research trials. But others argued that evidence based medicine, if practised knowledgably and compassionately, could accommodate basic scientific principles, the subtleties of clinical judgment, and the patient’s clinical and personal idiosyncrasies…
One of my pet peeves is reading an article that is either pro or con about something, but rather than starting with the conclusion and explaining the reasons, the author pretends neutrality and slides his/her argument in at the end as if it has been forced on him/her by the weight of evidence. I feel gamed by such an argument style. Hitler used it in Mein Kampf. Dr. Insel just did it with
Are Children Overmedicated? [see fore·told…]. So when I have an opinion, I try to say it up front in case you have a similar affliction. In this case, I’ve supplied an image to let you know how I feel about the notion of Evidence·Based·Medicine. I don’t like it. It feels like a trap. It is a trap.
Are Children Overmedicated? [see fore·told…]. So when I have an opinion, I try to say it up front in case you have a similar affliction. In this case, I’ve supplied an image to let you know how I feel about the notion of Evidence·Based·Medicine. I don’t like it.
Who could argue with something called Evidence·Based·Medicine? I’ve only had careers in science [hard and soft] all my life, living and breathing evidence based medicine. What’s the alternative? But as you read above, that’s not what the term actually means. So I’ve renamed what they are talking about as Algorithmic Medicine because that seems to fit best with what they actually mean when they say, "Tradition, anecdote, and theoretical reasoning from basic sciences would be replaced by evidence from high quality randomised controlled trials and observational studies, in combination with clinical expertise and the needs and wishes of patients." What that means in practice is "evidence from high quality randomised controlled trials and observational studies." Some reasons I don’t like Evidence·Based·Medicine are:
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The idea generalizes a small, short-term experiment on carefully selected subjects as a paradigm for large, heterogeneous group who may take the medication for years [as if such a transformation is scientifically justified – which it rarely is].
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It is built on the phantasy that is similar to the notion that building a model airplane that flies is the last step before going into production for jumbo jets.
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It opens a portal for companies with only conflicts of interest to easily insert their products into mainstream medicine effortlessly.
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following from number 2., it virtually guarantees corruption [as has been shown repeatedly in a variety of venues].
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While one motive of Evidence·Based·Medicine is to discourage sloppy "shooting from the hip," it replaces that with an even more dangerous sloppy dependence on rote and thoughtless practice.
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It has been regularly used to withhold services and treatment, denigrate anything subjective in medicine, and justify practices that are supported by trivial statistics rather than clinical effectiveness.
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It discourages the time honored method of evaluating medications by their performance in wide clinical practice.
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The people setting the guidelines have been not only often compromised, but also largely non-practitioners.
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It was itself an idealistic and naive experiment that failed its own clinical trial.
for starters… This article is by a group hoping to reform Evidence·Based·Medicine [the Evidence Based Medicine Renaissance Group] and I think they mean well. They want to restore clinical judgement, compassion, common sense to this concept that was instrumental in their loss in the first place. They conclude:
Much progress has been made and lives have been saved through the systematic collation, synthesis, and application of high quality empirical evidence. However, evidence based medicine has not resolved the problems it set out to address [especially evidence biases and the hidden hand of vested interests], which have become subtler and harder to detect. Furthermore, contemporary healthcare’s complex economic, political, technological and commercial context has tended to steer the evidence based agenda towards populations, statistics, risk, and spurious certainty. Despite lip service to shared decision making, patients can be left confused and even tyrannised when their clinical management is inappropriately driven by algorithmic protocols, top-down directives and population targets.
Such problems have led some to argue for the rejection of evidence based medicine as a failed model. Instead we argue for a return to the movement’s founding principles — to individualise evidence and share decisions through meaningful conversations in the context of a humanistic and professional clinician-patient relationship. To deliver this agenda, evidence based medicine’s many stakeholders — patients, clinicians, educators, producers and publishers of evidence, policy makers, research funders, and researchers from a range of academic disciplines — must work together. Many of the ideas in this paper are not new, and a number of cross sector campaigns with similar goals have already begun. We hope that our call for a campaign for real evidence based medicine will open up debate and invite readers to contribute [for example, by posting rapid responses on bmj.com].
As for me, if I never hear the term again, that would be just fine. I think Clinical Trials are a first shot at eliminating inert and grossly unsafe medications from our pharmacopoeia – nothing more. Their centrality has been a disaster as explained eloquently by Dr. Healy in his book Pharmageddon. The operative principle here is:
Fool me once, shame on you.
Fool me twice, shame on me.
For all his faults, we should thank the incendiary Dr. Healy for near-self-immolation in his efforts to bring the myths of “evidence-based medicine” to public attention.
Theoretically, it was a good idea when hatched in the ivory tower. But it was taken over by industry in the great Randian neo-liberal movement of the last 20 years.
The death of reality-based innovation has not gone unnoticed by even that bastion of capitalism Harvard. See http://m.dailykos.com/story/2014/06/15/1304208/-Harvard-Business-Review-calls-bullshit-on-today-s-capitalists
(Who would have thought that the philosophies of bad novelist Ayn Rand would have corrupted the biggest economy in the world?)
Harvard’s Clayton Christensen on Innovate by Looking for Problem Patterns — a practice that has been distinctly missing from psychiatry: http://youtu.be/Bq3H-gM0LXE
Confucius say: Evidence based medicine needs medicine based evidence.
I am not all that sure it was such a great idea even theoretically. Although the term sounds like something you’d be stupid not to support, what do you do with those not falling around the mean. I suppose that evidence-based medicine could slowly cull the herd of all those at the ends of the bell curve. Then the world would end up with only patients having a gene pool behaving similarly to the Norway rat’s. Some might actually like that as it would make health care easier and less expensive.
Thanks for the post. “Renaissance Group”?
Most people do not realise there is now a plethora of EB X’s where X represents another field outside medicine. EBP started the rot in 1997 with New Labour introducing Evidence-Based Policy. EB X has moved into fields like IT and management.
People working in these fields do not normally read medical journals just as those who read medical journals do not read journals in those other fields.
So depressingly 1) those responsible for the EBM mess are still trying to salvage their model and 2) it will take another 20-30 years for those working in other fields to realise EB X is unworkable nonsense with all the consequent harm done in the meantime.
I agree with your criticism of the way EBM has been (ab)used. But I think opposing EBM is like throwing the baby with the bathwater. Blind algorithms can do harm, but I see harm commonly being done by psychiatrists working idiosyncratically based on their “clinical experience”, giving their patients dangerous polypharmacy, based on anecdotes they for some reason remember. Humans are inherently biased in their observations. One recent example that comes to my mind is hearing a senior experienced colleague saying that he has “never seen methylphenidate induced tics”, while I, much less experienced, have already seen quite a few clear cut cases.
Gad,
Thanks for that comment! I’ll respond with an argument I should have included in the post, but I thank you for jump starting my old brain. Your point is the reason Evidence·Based·Medicine originated, as a check against such use of anecdote. But the opposite of Evidence·Based·Medicine [Algorithmic Medicine] is not Bad·Medicine. That’s a false dichotomy that has been quite expensive to all of us. “a senior experienced colleague saying that he has ‘never seen methylphenidate induced tics’” is simply wrong, unlikely to need a rule in place, an Algorithm, or a Clinical Trial to make right. It can be refuted with very simple facts – one or two cases of tics on Ritalin® that clear with discontinuation and reappear with challenge.
Clinical Trials are simply another kind of anecdote. In Paxil Study 329, they said, “Paroxetine is generally well tolerated and effective for major depression in adolescents.” That is both untrue and un-generalizable, but because it fits the Evidence·Based·Medicine [Algorithmic Medicine] criteria, it was seen as truth and caused a lot of damage. And Paxil Study 329 wasn’t an isolated event, it was an industry-wide epidemic – capitalizing on the loophole of Evidence·Based·Medicine’s pseudo-truth.
Your own clinical experience quickly refutes “a senior experienced colleague saying that he has ‘never seen methylphenidate induced tics’” but it’s hard to have enough personal experience with “Paroxetine is generally well tolerated and effective for major depression in adolescents.” The inappropriate centrality of Clinical Trials actually makes us doubt our own eyes.
Again, thanks for the comment…
Yes EBM has been poorly applied, I think because professionals and patients alike do not have good ways of evaluating evidence and integrating that evaluation into their own financial limits, willingness, capacity, etc. There are ways to evaluate quality of evidence, and the lack of the most quality evidence (which can be wrong but designed to be least likely to be) doesn’t meant there isn’t evidence to base decisions on, just that greater uncertainties (which can mean potential hope and let-down) have to be tolerated. Evaluators, health professionals, and policy-makers should understand expert opinion and anecdote are evidence, and sometimes they are the best evidence available, and sometimes they are right on for the right reasons (sometimes they are right on for the wrong reasons too). This kind of evidence should probably be used to frame and design research agendas to further better understanding. However, when better quality evidence exists, that also should be taken into account, and probably with more weight, than just anecdote substantiated opinion.
I think the failures of applied EBM have highlighted a bigger problem, that our applied process of “science” is broken. Funding, publishing, selective publishing, dissemination, conflict of interests, tenure-seeking, etc., have distorted the peer-review process of trusted journals leaving an evidenced lack of confidence in our formalized process of building scientific literature. I think that this process needs to be fixed before EBM, or just any medicine, can be rehabilitated.
Nathan,
Excellent points all. My complaint is not with evidence based medicine or, as Dr. Carroll points out above, medicine based evidence, it’s with Evidence·Based·Medicine which is something else, [Algorithmic Medicine is the best I can do]. These Algorithms which have become Treatment·Guidelines have been treated as Dogma, and used for a number of things that are inappropriate [remember TMAP!] such as Managed Care reimbursement schedules or denial of services. But worst of all, they’ve been a conduit for rampant corruption. In Pharmageddon, Dr. Healy makes a point that it took me a while to understand. The over-reliance on Clinical Trials has clinicians ignoring the most powerful tools they have – observation and common sense. The dangers of anecdotalism are well known, but algorithms and guidelines are at least equally dangerous, maybe more-so.
So I have no complaint about Clinical Trials and Guidelines so long as they are carefully watched and I’m sure not advocating “shooting from the hip.” I’m concerned about their Dogmatic use. I think you say it well, “However, when better quality evidence exists, that also should be taken into account, and probably with more weight, than just anecdote substantiated opinion” with an emphasis on weight rather than Dogma. That has been true since long before Evidence·Based·Medicine became the coin of the realm…
Mickey, have you ever researched and reported on the background of the Texas Medication Algorithm Project? My recollection is that the project came about due to then Gov. Bush’s support plus funding by the State of Texas and pharma. It is simple: It replaces thinking by, in effect manualizing what passes these days for “psychotherapy” and medication management, and plays well with Evidence Based Practice.
Dr. Nardo, I agree with your queasiness about Evidence Based Medicine, and with each point of your arguments here. That said, I want to encourage you and your readers to explore the recent work of Trisha Greenhalgh (the lead author of the paper you reference here). She was a key person in getting EBM off the ground 20 years ago, with the article How to Read a Paper. Her evolution since then is what interests me. She has become more and more disenchanted with EBM as a movement, and has put more and more of her energy into “Narrative Based Medicine.” Here’s a link to a BMJ article (for those with access) on the subject:
http://www.bmj.com/content/318/7179/323.1
For my taste, she is deeply informed and incredibly wise in her arguments and aspirations for how we might thoughtfully and humanely use both population-based statistics and individually based, contextully informed, narrative information in providing medical care.
Ed,
Just put TMAP into the search box below. I even went for the trial in Austin. I’m TMAP savvy and in the process, made a really good friend – Allen Jones.
Gene,
Good to hear from you. I just read number 1 of 5 of those narrative articles and am printing out the rest. I have liked Trisha Greenhalgh, but have worn out with EBM [obviously]. The narrative articles, on the other hand, are right down my alley and a refreshing break from the Data Transparency wars. Thanks so much for sending them…