1) While EBM principles themselves are sound, the evidence base that EBM relies upon has problems like industry influence over the research agenda, manipulation of studies, and publication bias. 2) To achieve "Real EBM", patients must demand better evidence presented in a more personalized way, clinical training must focus on expert judgement and shared decision making, and evidence producers must consider usability. 3) Independent funders and a broader, more interdisciplinary research agenda are needed to shape high quality evidence production and dissemination. Changes are also needed to drug/device approval and payment schemes to better reward value over volume.

1. EBM Principles
Are Not In
Crisis
Terry Shaneyfelt, MD, MPH
Department of Medicine
University of Alabama at Birmingham
EBMTeacher.com
@EBMTeacher

2. Disclosures
• Associate editor for BMJ EBM ($)
• Member of American College of Physicians
Performance Measurement Committee
• No speakers bureaus, industry grant money, industry
stocks

5. ACPJC March/April 2002

6. EBM: A Movement in Crisis?

7. EBM: A Movement in Crisis?
Problems with the evidence base
• Industry sets the research agenda
• Manipulating studies
• Publication bias
• Out of date
• Conflicts of interest / Affect heuristic

8. Industry shouldn’t be
sponsoring studies

10. How do we get “Real” EBM?
• Patients must demand better evidence, better
presented, better explained, and applied in a more
personalized way
• Clinical training must go beyond searching and
critical appraisal to hone expert judgment and
shared decision making skills
• Producers of evidence summaries, guidelines, and
decision support tools must take into account who
will be using them, for what, and under what
circumstances
• Publishers must demand studies meet usability and
methodological standards

11. How do we get “Real” EBM?
• Independent funders must
increasingly shape the
production, synthesis, and
dissemination of high quality
clinical and public health
• Research agenda must
become broader and more
interdisciplinary, embracing the
experience of illness, the
psychology of evidence
interpretation, the sharing of
evidence, and how to prevent
harm from overdiagnosis

12. “Real” EBM = different evidence
developed by different people in a
different format

13. Rewards what we have
• Goal of industry  drugs/devices that get paid for
• What 3rd party payers pay for is what MEDICARE
pays for
• What MEDICARE pays for is what the FDA approves
• FDA requires proof of efficacy and safety
o Not cost-effectiveness
o Not any specific degree of effectiveness
o Doesn’t matter how many other similar drugs are out there

15. Real EBM Movement

16. How do we take back
EBM?
• The FDA (& equivalent agencies) should:
o Demand all studies be registered
o Demand properly conducted trials with hard clinical outcomes (currently
planned trials only reviewed to ensure safety to patients )
o Demand publication of all studies
o Consider costs and competing array of treatments
• Intensify EBM skills training
• Quality (guidelines) industry needs to be controlled

17. EBM principles are not
in crisis
• Evidence-based moniker has been high jacked
• Algorithmic medicine is antithetical to EBM
• EBM is designed to deal with multimorbidity
• Need lots of changes in the world for “REAL EBM”
o Time
o Overhaul of drug/device approval/payment scheme
o Need experts 1st for “expert judgment”- clinical training improvements

18. EBM principles are not in crisis
• Good EBM skills can detect problems in the evidence
• Unintended consequences of this movement
• Critical appraisal skills are still critical
o “If peer review was a drug it would never be allowed onto the market. Peer
review would not get onto the market because we have no convincing
evidence of its benefits but a lot of evidence of its flaws.”
o “There seems to be no study too fragmented, no hypothesis too trivial, no
literature citation too biased or too egotistical, no design too warped, no
methodology too bungled, no presentation of results too inaccurate, too
obscure, and too contradictory, no analysis too self-serving, no argument too
circular, no conclusions too trifling or too unjustified, and no grammar and
syntax too offensive for a paper to end up in print.”—Drummond Rennie