Medical Reversal

OVERVIEW

  • Medical reversal is the phenomenon of a new superior trial arising that contradicts current clinical practice.
  • Many claims that specific treatments have a benefit have turned out not to be true.

REASONS FOR MEDICAL REVERSAL

The initial claim may have been:

  • made from a flawed understanding of pathophysiology
  • based on poor quality studies
  • based on studies using surrogate outcomes rather that patient-orientated outcomes that matter
  • affected by publication bias and selective reporting of results due to the publication process (see Dogma and Pseudoaxioms for how the publication process distorts science)
    — high profile journals may be more likely to publish articles with more ‘sensational’ claims that, even if their methodologies are sound, are more likely to be aberrations and subsequently reversed
    — trials with positive results are more likely to be published, and more likely to be published in high profile journals
  • made by dishonest investigators  (e.g. Joachim Boldt)
  • based on publications subject to the malign influence of Big Pharma or other conflicts of interest

EXAMPLES OF MEDICAL REVERSAL

Flawed theory or small trials

  • stress and hyperacidity as a cause of peptic ulcer disease (PUD) replaced by the central role of Helicobacter pylori in PUD
  • steroids and prophylactic hyperventilation for traumatic brain injury
  • military anti-shock trousers suit for hypovolaemic shock
  • aggressive volume resuscitation for shock associated with penetrating truncal trauma

Positive results from trials based on surrogate measures (i.e. disease-oriented outcomes)  subsequently overturned by trials based on patient-oriented outcomes

  • high-dose steroids for spinal cord injury
  • calcium in cardiac arrest
  • cyclo-oxygenase-2 enzyme (COX-2) inhibitors
  • early decompressive craniectomy in traumatic brain injury
  • vest CPR for out-of-hospital cardiac arrest
  • drotrecogin alfa for sepsis

HARMS FROM MEDICAL REVERSAL

  • patients potentially harmed by being exposed to treatments incorrectly thought to be beneficial until further research provides a correction
  • ongoing exposure of patients to treatments until ‘medical reversal’ enters clinical practice (typically about 10 years)
  • patients’ loss of trust in the medical system from recurrent medical reversal

EVIDENCE

  • A study by Prasad et al 2013 found that out of the 2004 ‘Original Articles’ published in the New England Journal of Medicine from 2001 to 2010, 363 articles tested an established therapy. Of these 146 (40.2%) reversed that practice, whereas 138 (38.0%) reaffirmed it.

References and Links

LITFL

Journal articles

  • Fatovich DM. Medical reversal: What are you doing wrong for your patient today? Emerg Med Australas. 2013 Feb;25(1):1-3. doi: 10.1111/1742-6723.12044. PubMed PMID: 23379445. [Free Full Text]
  • Ioannidis JP. Why most published research findings are false. PLoS Med. 2005 Aug;2(8):e124. Epub 2005 Aug 30. PubMed PMID: 16060722; PubMed Central PMCID: PMC1182327.
  • Ioannidis JP. How Many Contemporary Medical Practices Are Worse Than Doing Nothing or Doing Less? Mayo Clin Proc. 2013 Jul 10. doi:pii: S0025-6196(13)00403-5. 10.1016/j.mayocp.2013.05.010. [Epub ahead of print] PubMed PMID: 23871231. [Free Full Text]
  • Prasad V, Gall V, Cifu A. The frequency of medical reversal. Arch Intern Med. 2011 Oct 10;171(18):1675-6. doi: 10.1001/archinternmed.2011.295. Epub 2011 Jul 11. PubMed PMID: 21747003. [Free Full Text]
  • Prasad V, Cifu A, Ioannidis JP. Reversals of established medical practices: evidence to abandon ship. JAMA. 2012 Jan 4;307(1):37-8. doi: 10.1001/jama.2011.1960. PubMed PMID: 22215160.
  • Prasad V, Vandross A, Toomey C, Cheung M, Rho J, Quinn S, Chacko SJ, Borkar D, Gall V, Selvaraj S, Ho N, Cifu A. A Decade of Reversal: An Analysis of 146 Contradicted Medical Practices. Mayo Clin Proc. 2013 Jul 12. doi:pii: S0025-6196(13)00405-9. 10.1016/j.mayocp.2013.05.012. [Epub ahead of print] PubMed PMID: 23871230. [Free Full Text] (includes a video commentary by the lead author)
  • Young NS, Ioannidis JP, Al-Ubaydli O. Why current publication practices may distort science. PLoS Med. 2008 Oct 7;5(10):e201. doi: 10.1371/journal.pmed.0050201. PubMed PMID: 18844432; PubMed Central PMCID: PMC2561077.

CCC 700 6

Critical Care

Compendium

Chris is an Intensivist and ECMO specialist at the Alfred ICU in Melbourne. He is also the Innovation Lead for the Australian Centre for Health Innovation at Alfred Health and Clinical Adjunct Associate Professor at Monash University. He is a co-founder of the Australia and New Zealand Clinician Educator Network (ANZCEN) and is the Lead for the ANZCEN Clinician Educator Incubator programme. He is on the Board of Directors for the Intensive Care Foundation and is a First Part Examiner for the College of Intensive Care Medicine. He is an internationally recognised Clinician Educator with a passion for helping clinicians learn and for improving the clinical performance of individuals and collectives.

After finishing his medical degree at the University of Auckland, he continued post-graduate training in New Zealand as well as Australia’s Northern Territory, Perth and Melbourne. He has completed fellowship training in both intensive care medicine and emergency medicine, as well as post-graduate training in biochemistry, clinical toxicology, clinical epidemiology, and health professional education.

He is actively involved in in using translational simulation to improve patient care and the design of processes and systems at Alfred Health. He coordinates the Alfred ICU’s education and simulation programmes and runs the unit’s education website, INTENSIVE.  He created the ‘Critically Ill Airway’ course and teaches on numerous courses around the world. He is one of the founders of the FOAM movement (Free Open-Access Medical education) and is co-creator of litfl.com, the RAGE podcast, the Resuscitology course, and the SMACC conference.

His one great achievement is being the father of two amazing children.

On Twitter, he is @precordialthump.

| INTENSIVE | RAGE | Resuscitology | SMACC

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