Evidence-based medicine: A movement in crisis?

By Trisha Greenhalgh, Jeremy Howick, and Neal Maskrey
for the Evidence-Based Medicine Renaissance Group
BMJ, June 13, 2014

It is more than 20 years since the evidence-based medicine working group announced a “new paradigm” for teaching and practicing clinical medicine. Tradition, anecdote, and theoretical reasoning from basic sciences would be replaced by evidence from high quality randomized controlled trials and observational studies, in combination with clinical expertise and the needs and wishes of patients. …

[M]any who support evidence-based medicine in principle have argued that the movement is now facing a serious crisis. … Below we set out the problems and suggest some solutions. …

The first problem is that the evidence based “quality mark” has been misappropriated and distorted by vested interests. In particular, the drug and medical devices industries increasingly set the research agenda. …

The second aspect of evidence-based medicine’s crisis … is the sheer volume of evidence available. … [T]he number of clinical guidelines is now both unmanageable and unfathomable. …

Risk assessment using “evidence-based” scores and algorithms … now occurs on an industrial scale, with scant attention to the opportunity costs or unintended human and financial consequences. …

Well intentioned efforts to automate use of evidence through computerised decision-support systems, structured templates, and point-of-care prompts can crowd out the local, individualised, and patient initiated elements of the clinical consultation. For example, when a clinician is following a template-driven diabetes check-up, serious non-diabetes related symptoms that the patient mentions in passing may not be documented or acted on. … Templates and point-of-care prompts also contribute to the creeping managerialism and politicization of clinical practice. …

[A]s the population ages and the prevalence of chronic degenerative diseases increases, the patient with a single condition that maps unproblematically to a single evidence-based guideline is becoming a rarity. … Multimorbidity … seems to defy efforts to produce or apply objective scores, metrics, interventions, or guidelines. Increasingly, the evidence-based management of one disease … may cause or exacerbate another. …

http://www.bmj.com/content/348/bmj.g3725

In this paper, Trisha Greenhalgh and two British colleagues present an intelligent review of the impediments encountered by the evidence-based medicine (EBM) movement. The impediments listed by the authors can be grouped into two categories: the distortion of research by drug and device manufacturers, and the misuse of guidelines.

The authors make the expected criticism of drug and device manufacturers. But inexplicably they fail to indict the culprits behind the misuse of guidelines, namely, managed care and pay-for-performance (P4P) proponents – those who think doctors should be subjected to rewards and punishment based on how well they perform according to guidelines.

The problem is that the authors have conflated EBM with managed care, or “creeping managerialism” as they put it. (In the U.K., “managerialism” appears to be synonymous with “managed care.”) That is regrettable but understandable. EBM has been appropriated by the managed care movement to justify shifting authority from doctors and patients to bureaucrats.

Since the formation of the EBM movement in the U.K. and North America in the early 1990s, managed care advocates have enthusiastically insisted that doctors abide by the principles of EBM, all the while refusing to impose upon themselves a similar set of standards. (Is it not odd that there is no analogous movement for evidence-based health policy?)

The EBM movement has been controversial from the beginning. At first blush, that seems odd. EBM’s architects defined EBM in seemingly nondebatable, mother-and-apple-pie terms. “Evidence-based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients,” wrote David Sackett, one of the founders of the movement in a 1996 paper for BMJ.

In that paper Sackett et al. made it clear they were not motivated by a desire to enforce “cook book medicine” on behalf of insurance companies and cost cutters. “Some fear that evidence based medicine will be hijacked by purchasers and managers to cut the costs of health care,” they wrote. “This would … be a misuse of evidence-based medicine. … Doctors practising evidence-based medicine … may raise rather than lower the cost of their [patients’] care.”

But the critics turned out to be correct: EBM was quickly “hijacked” by the managed care movement. By the early 2000s, P4P had become an influential managed care fad, and P4P proponents routinely cited EBM principles to justify P4P.

The solution is not to conflate EBM with P4P. The solution is to make a clear distinction between problems caused by the violation of the rules of science and those caused by managed care.

For example, if a group promotes a guideline based upon biased research (a problem caused by the violation of the rules of science), the bias should be publicized and the guideline should be recalled or amended. But if the problem is that a scientifically sound guideline (one based on EBM principles) has been hooked to a P4P scheme, and that scheme causes doctors to ignore patients’ priorities, the appropriate response is to criticize the P4P fad, not the guideline or EBM.

A recent BMJ paper co-authored by Greenhalgh illustrates the need for this distinction. The investigators observed nurse-led encounters with British patients to examine the effect of the U.K.’s P4P program on the nurse-patient encounter. The paper provided several examples of how the nurses’ need to check boxes on a computer screen interfered with their ability to respond to their patient’s concerns. Here is an example:

A frail-looking 86-year-old man struggled into the clinic, barely able to walk. He was very deaf. He hung his walking stick over his chair and grimaced as he sat down, looking as if he was in pain. The nurse said loudly “We’ve called you in to look at you from the heart point of view. I know you have a lot of other things going on but we’ve called you in to look at your heart.” She then asked “How often do you use the angina tablet under your tongue?’ The patient replied in a way which made his most pressing concern clear: “Not much … for the simple reason that I can only crawl like a tortoise.”

Nurse: “and the simvastatin?”

Patient: “no … I stopped that. I think it’s giving me diarrhoea. These hearing aids are not very good you know. I’ve had it adjusted several times but I’m really disappointed. I had hoped for better than this.”

The nurse’s statement, “I know you have a lot of other things going on but we’ve called you in to look at your heart” performs two contrasting functions. On the one hand, she acknowledges the difficulty inherent in separating out his ‘heart’ problem from his other illnesses and wider experiences, making it legitimate for the patient to frame his heart problems in a broader context. However, in the next part of her utterance “but we’ve called you in to look at your heart”, she exhibits what discourse analysts call a ‘scale jump’. She shifts quickly from an individual, unique ‘here and now’ framing (“I know you have …”) to a more general institutional framing (“we’ve called you in …”). This shift indexes what is most relevant and implies certain limits around what may happen in this consultation.

The patient responds by juxtaposing his prime concerns with the ‘core’ concerns of this clinic. First, he rarely uses his angina tablet – but only because his mobility problems outweigh his angina. Then his concern about simvastatin moves swiftly into a complaint about his hearing aids. Neither mobility nor deafness are pursued by the nurse (or recorded on the electronic record); they are ‘unremarkable’ problems in this (heart) clinic.

The problem here is not a scientific one – the issue is not whether evidence indicates patients with coronary artery disease should take statins. The problem is that the patient’s concerns were neither heeded nor documented because the nurse’s priorities were set by her computer, not her patient. The patient’s authority to set his own agenda was undermined by the U.K.’s massive P4P scheme.

One of the more cloying labels invented by the managed care movement in the last 15 years is the phrase “patient-centered care.” The great irony of this saccharine phrase is that it is promoted by groups that have undermined patient autonomy by promoting report cards and P4P.

The most preeminent among these groups is the Institute of Medicine (see Crossing the Quality Chasm, 2001). For a quarter century the IOM has also been promoting the use of electronic medical records (EMRs) and for the last 15 years the IOM has promoted P4P.

That combination – EMRs plus P4P – deserves a name. I propose “computer-centered care.” The story about the old man with heart disease I quoted above illustrates how computer-centered care (supported by the IOM) sabotages patient autonomy (aka “patient-centered care,” something the IOM also promotes).

The story illustrates why Greenhalgh et al. should have distinguished EBM from computer-centered care. EBM is not the problem. The problem is computer-centered care.

Kip Sullivan, J.D., is a member of the steering committee of the Minnesota chapter of Physicians for a National Health Program. His writing has appeared in The New York Times, The Nation, The New England Journal of Medicine, Health Affairs, the Journal of Health Politics, Policy and Law, and the Los Angeles Times.