the metablog

Posts tagged Evidence based medicine.

The 4th Horseman: Research Fraud & Mountains of Fujii

The fourth and final horseman of the medical research apocalypse is the scourge of medical research fraud. Although certainly not a new problem, the scale and potential impact of research deceit is unlike anything faced previously.

Academic fabrication, falsification, and plagiarism (FFP) make up the breadth of academic fraud – and sadly, anesthesia is the number one specialty by volume. In 2012 our eyes were opened to the sheer scale of the problem as the largest medical research fraud in history was exposed.

Trust, responsibility and the Fujii fraud

Medical research involves a lot of trust. The trust of patients and the public, the trust of publishers and the trust of the research-consuming clinician. Unfortunately we often overlook our responsibility to ensure that our trust is not misused.

"...with increasing amazement, we notice that the results reported by Fuji et al. are incredibly nice ..." wrote Kranke, Apfel and Roewer in their April 2000 letter, politely challenging Yoshitaka Fujii's PONV research.1

And so began the very slow unravelling of the biggest academic fraud in the history of medicine. Despite a meaningless response from Fujii to that first challenging letter, there was no investigation or further questioning from the various anesthesia journals. In fact Anesthesia & Analgesia went on to publish another 11 articles by Fujii over the next decade.2,3

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  1. Kranke P, Apfel CC, Roewer N, Fujii Y. Reported data on granisetron and postoperative nausea and vomiting by Fujii et al. Are incredibly nice! Anesth Analg. 2000 Apr;90(4):1004-7. 

  2. To their credit A&A were instrumental in ultimately uncovering the fraud and have lead the charge in undoing the damage inflicted by Fujii. Shafer SL. Fujii Statement Of Concern. Anesth Analg. 2012 Mar 7. 

  3. Yentis SM. Lies, damn lies, and statistics. Anaesthesia. 2012 May;67(5):455-6. 

The 3rd Horseman: Significance & Relevance

Arguably the most important piece of the evidence-based-medicine puzzle is when we ask ourselves:

"Is this evidence significant? – Is this relevant to my patients and my practice?"

When we talk about the 'quality' of a published research work we largely mean what the epidemiologists refer to as 'internal validity' – the extent to which the study's conclusions are actually warranted given the methodology and results. Internal validity looks only at the study design, conduct and interpretation, and takes into account bias and confounders. While important, internal validity is not alone sufficient.

The significance of a piece of evidence to medicine in general, along with it's relevance to our own practice, is referred to as the external validity. I think that for your and my practice this is often what matters most.

Really, external validity just describes how well the results and conclusions can be generalized to situations and people beyond those in the study.

I think of significance as the cumulative generalizability of a piece of evidence for the specialty and for wider medicine, integrated with how well the evidence agrees with what is already known. Relevance describes how applicable the evidence is to my hospital, my practice – and my patients.

It has significance for you, and relevance for me.

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The 2nd Horseman: Quality Evidence

Our understanding of what makes for quality medical research has improved dramatically over the past three decades. We understand that research must be ethical; should be reproducible; free of bias, so that we may make accurate conclusions; and that confounders be minimised and controlled for. We understand that prospective is best, and large blinded randomized trials are king.

We can articulate that a study must be appropriately powered to answer the question we are asking – but also not over-powered so that we waste resources and goodwill, or continue a study after an answer is known.

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The 1st Horseman: Publication Overload

The number of new medical articles published each month is accelerating. PubMed has over 23 million indexed going back to 19661, adding around 500,000 every year – but that's just the articles they index. There are an estimated 50 million scholary articles in total ever written 2, and currently over 28,000 peer-reviewed journals in print, publishing almost 2 million new articles in 2012 – and that's growing by 3% every year.3

If we focus only on MEDLINE® citations (publications indexed with MeSH, Medical Subject Headings) the number of publications each year is increasing exponentially. The graph below shows annual (not cumulative) MEDLINE® citations. The trendline in orange highlights the challenge of staying-up-to-date: annual medical publications is not just increasing, its accelerating.

Publication Overload

source: http://www.nlm.nih.gov/bsd/medline_cit_counts_yr_pub.html

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  1. Wikipedia: PubMed. 

  2. Jinha, Arif E. Article 50 million: an estimate of the number of scholarly articles in existence. Learned Publishing, Volume 23, Number 3, July 2010, pp. 258-263(6). 

  3. The STM report 2012 - An overview of scientific and scholarly journal publishing

The Four Horsemen of the Medical Research Apocalypse

The evidence-based medicine movement started excitedly in the 1990s, filled with much promise and hope. The way we practice medicine has been improved by EBM, along with the health of our patients. However it has not been all smooth sailing, and the challenges to evidence-based medicine are growing not lessening.

While we know more about the human body, critical care, anesthesia, and resuscitation than ever before, it is conversely more difficult to integrate evidence and guide decisions where they matter: for an individual patient.

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